Tyvek Self-Seal Pouch

GUDID D8305608162

Tyvek 8” x 16” Self-Seal Pouch

GS Medical Packaging Inc

Sterilization packaging, single-use

• Primary Device ID: D8305608162
• NIH Device Record Key: 4c2ee500-c3a9-4f9a-9fa8-1c8f5b351949
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyvek Self-Seal Pouch
• Version Model Number: 560816
• Company DUNS: 246113039
• Company Name: GS Medical Packaging Inc
• Device Count: 200
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8305608160 [Unit of Use]
HIBCC	D8305608161 [Primary]
HIBCC	D8305608162 [Package]; Contains: D8305608161; Package: Cardboard Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141412

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-10
• Device Publish Date: 2025-01-02

On-Brand Devices [Tyvek Self-Seal Pouch]

• D8305610152: Tyvek 10” x 15” Self-Seal Pouch
• D8305608162: Tyvek 8” x 16” Self-Seal Pouch
• D8305607132: Tyvek 7” x 13” Self-Seal Pouch
• D8305606132: Tyvek 6” x 12.5” Self-Seal Pouch
• D8305605152: Tyvek 5” x 15” Self-Seal Pouch
• D8305604092: Tyvek 3.5” x 9” Self-Seal pouch