Generic

GUDID D8305514400

TYVEK ROLL 10" X 100'

GS Medical Packaging Inc

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

• Primary Device ID: D8305514400
• NIH Device Record Key: d73d3f1d-ec1d-418a-ba95-f70bf09247f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Generic
• Version Model Number: 551440
• 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	D830551440 [Primary]
HIBCC	D8305514400 [Package]; Contains: D830551440; Package: POLY BAG [1 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 [Generic]

• D8305716202: TYVEK AUTOCLAVABLE BAG 15.75"X18.25"
• D8305711142: TYVEK AUTOCLAVABLE BAG 11"X13.75"
• D8305612182: TYVEK S/S POUCH 12" X 18"
• D8305612152: TYVEK S/S POUCH 12" X 15"
• D8305608132: TYVEK S/S POUCH 7.5" X 13"
• D8305605102: TYVEK S/S POUCH 5.25" X 10"
• D8305518311: TYVEK H/S POUCH 18" X 31"
• D830551442PC0: TYVEK ROLL 12"X200'
• D8305514420: TYVEK ROLL 12" X 100'
• D8305514400: TYVEK ROLL 10" X 100'
• D8305514380: TYVEK ROLL 8" X 100'
• D830551436PC0: TYVEK ROLL 6"X200'
• D8305514360: TYVEK ROLL 6" X 100'
• D8305514340: TYVEK ROLL 4" X 100'
• D8305514330: TYVEK ROLL 3" X 100'
• D8305514320: TYVEK ROLL 2" X 100'
• D8305512182: TYVEK H/S POUCH 12" X 18"
• D8305512152: TYVEK H/S POUCH 12" X 15"
• D830551015T2: TYVEK H/S POUCH 10" X 15"
• D8305510152: TYVEK H/S POUCH 10" X 15"
• D8305508122: TYVEK H/S POUCH 8" X 12"
• D8305506102: TYVEK H/S POUCH 6" X 10
• D8305506072: TYVEK H/S POUCH 6" X 7"
• D8305504092: TYVEK H/S POUCH 4" X 9"
• D8305503072: TYVEK H/S POUCH 3" X 7"
• D8305503052: TYVEK H/S POUCH 3" X 5"