STERIL-PEEL

GUDID D830222103B2

UNPRINTED SS POUCH 7.5" X 13"

GS Medical Packaging Inc

Sterilization packaging, single-use Sterilization packaging, single-use

• Primary Device ID: D830222103B2
• NIH Device Record Key: f4ba5c79-9647-4192-97ae-29477368f5e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIL-PEEL
• Version Model Number: 222103B
• Company DUNS: 246113039
• Company Name: GS Medical Packaging Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D830222103B1 [Package]; Contains: D830222103B9; Package: CARDBOARD BOX [200 Units]; In Commercial Distribution
HIBCC	D830222103B2 [Package]; Contains: D830222103B1; Package: CARDBOARD BOX [5 Units]; In Commercial Distribution
HIBCC	D830222103B9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953829

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-02-07

On-Brand Devices [STERIL-PEEL]

• D8302228162: STERIL-PEEL SS POUCH 8" X 16"
• D8302225552: STERIL-PEEL SS POUCH 12" X 15"
• D830222103B2: UNPRINTED SS POUCH 7.5" X 13"
• D8302214341: STERIL-PEEL TUBING/ROLL 4" X 100'