SpecificationBrand : DANFER
BulletPoint1 : Triple Seal, Triple Heat Process - The edges of the pouch are sealed by three separately heat-sealed rails to prevent separation or tearing by instruments. The seals are heated and cooled three times in the production process to ensure a secure seal.
BulletPoint2 : Blue Tinted Transparent Film - Provides easy viewing of instruments and identifies any punctures or tears in the film.
BulletPoint3 : Medical Grade Paper - Medical grade paper, wet strength treated for high performance.
BulletPoint4 : Wide Self-Seal Adhesive Strip - to easily and securely seal pouch.
BulletPoint5 : Perforated Fold - Helps in folding the adhesive strip to form a tight seal.
Color : Blue, Green, Transparent
FdaDeviceClassification : ii
FdaIndicationOfUse : otc
FdaInstructionsForUseType : consumer
FdaLabelType : consumer
FdaPremarketApprovalNumber510k : K193561
FdaPremarketApprovalNumberPma : K193561
IncludedComponents : A box of 200 Self-Sealing Sterilization Pouch
ItemName : Disposable Self Seal Sterilization Pouch 5.25" x 11", 200 per Box, Disposable Medical Device Sterilization Pouch (5 1/4" x11", 200pcs)
ItemPackageDimensions_Height : 29.21 centimeters
ItemPackageDimensions_Length : 5.8928 centimeters
ItemPackageDimensions_Width : 13.7922 centimeters
ItemTypeKeyword : professional-medical-sterilization-pouches
Manufacturer : Weihai Xingtai Packaging Products Co.,Ltd.
NumberOfBoxes : 1
NumberOfItems : 200
PartNumber : 3017220525
ProductDescription :
- Triple Seal, Triple Heat Process - The edges of the pouch are sealed by three separately heat-sealed rails to prevent separation or tearing by instruments. The seals are heated and cooled three times in the production process to ensure a secure seal.
- Blue Tinted Transparent Film - Provides easy viewing of instruments and identifies any punctures or tears in the film.
- Corner Tack Seals - Prevent corners of the pouch from curling after the sterilization process.
- Thumb Notch - Makes opening the pouch easy.
- Process Indicators - Large arrows that change colors, making it easy to confirm sterilization is complete.
Instructions For use
- Put clean and dry items into the pouch correctly, tear off the release paper of the double-sided tape on the self-sealing pouch, fold the paper along the dotted line by hand, squeeze it down along the center position, and close the sealing part without gaps to complete the sealing.
- Pay attention to the direction of sharp objects to avoid damage to the self-seal pouch.
- Place the sealed sterilization pouch in a paper-to-paper manner, and then place it in a high-temperature steam sterilization or ethylene oxide sterilization equipment, try not to squeeze it too much during sterilization, and proceed according to the conventional sterilization in method, attach label instructions.
- Confirm the discoloration of the sterilization process Indicator: The high-temperature steam sterilization indicator changes from blue to gray-black, and the ethylene oxide sterilization indicator changes from pink to yellow-brown.
- Store the sterilized pouch in a dry, dark, and clean area for later use.
- When you need to use the sterilized items in the self-seal pouch, peel off the sterilization pouch in the direction of the peeling instruction to take out the items.
ProductSiteLaunchDate : 2023-08-17T07:01:41.278Z
RegulatoryComplianceCertification : K193561
Size : 5 1/4" x 11"
SupplierDeclaredDgHzRegulation : not_applicable
SupplierDeclaredHasProductIdentifierExemption : 1
TemperatureRating : Ambient: 15 to 25 C (59 to 77 F)