PolyWear

GUDID 00855956008163

Smooth Lightweight Polyethylene Gowns - Large Blue, 15 Gowns/Dispenser

POLYCONVERSIONS, INC.

Surgical/examination garment kit

• Primary Device ID: 00855956008163
• NIH Device Record Key: c3f1a08f-6075-4a18-bea0-306b7cd6c9a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyWear
• Version Model Number: 10500
• Company DUNS: 825056401
• Company Name: POLYCONVERSIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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
GS1	00855956008163 [Primary]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

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: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [PolyWear]

• 10855956008238: Smooth Lightweight Polyethylene Gowns - Blue XXL, 75 Gowns/Case Bulk
• 10855956008153: Smooth Lightweight Polyethylene Gowns - Large Blue, 100 Gowns Bulk/Case
• 00855956008255: Embossed Lightweight Polyethylene Gowns - Large Blue, 100 Gowns/Case Bulk
• 00855956008248: Embossed Lightweight Polyethylene Gowns - Large Blue
• 00855956008231: Smooth Lightweight Polyethylene Gowns - Blue XXL
• 00855956008224: Smooth Lightweight Polyethylene Gowns - Blue XL, 75 Gowns/Case
• 00855956008217: Smooth Lightweight Polyethylene Gowns - Blue XL
• 00855956008200: Embossed Lightweight Polyethylene - Large Blue, 5 Dispensers/Case (75 Gowns)
• 00855956008194: Embossed Lightweight Polyethylene - Large Blue, 15 Gowns/Dispenser
• 00855956008187: Embossed Lightweight Polyethylene - Large Blue
• 00855956008170: Smooth Lightweight Polyethylene Gowns - Large Blue, 5 Dispensers/Case (75 Gowns)
• 00855956008163: Smooth Lightweight Polyethylene Gowns - Large Blue, 15 Gowns/Dispenser
• 00855956008156: Smooth Lightweight Polyethylene Gowns - Large Blue