STERIL-PEEL

GUDID D8302225552

STERIL-PEEL SS POUCH 12" X 15"

GS Medical Packaging Inc

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

• Primary Device ID: D8302225552
• NIH Device Record Key: e5da898b-9c3f-409c-8171-7e774ec5ec7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIL-PEEL
• Version Model Number: 222555
• 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	D830222555 [Primary]
HIBCC	D8302225551 [Package]; Contains: D830222555; Package: CARDBOARD BOX [200 Units]; In Commercial Distribution
HIBCC	D8302225552 [Package]; Contains: D8302225551; Package: CARDBOARD BOX [2 Units]; In Commercial Distribution

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: 2016-10-06

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'