POSS Medical

GUDID 00850053354694

POSS Medical Sterile AAMI Lvl 3 Surgical Soft Gown Large, Reinforced

Poss, LLC

Surgical gown, single-use

• Primary Device ID: 00850053354694
• NIH Device Record Key: 7ee395ca-bcd7-4225-b558-78bd60ff076f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POSS Medical
• Version Model Number: P103150
• Company DUNS: 066882769
• Company Name: Poss, LLC
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850053354694 [Primary]
GS1	00850053354700 [Package]; Package: CASE [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220665

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [POSS Medical]

• 00850053354687: POSS Medical Sterile AAMI Lvl 4 Surgical Soft Gown XL, Full Reinforcement
• 00850053354748: POSS Medical Sterile AAMI Lvl 3 Surgical Soft Gown 2XL, Reinforced
• 00850053354724: POSS Medical Sterile AAMI Lvl 3 Surgical Soft Gown XL, Reinforced
• 00850053354694: POSS Medical Sterile AAMI Lvl 3 Surgical Soft Gown Large, Reinforced