Isolation Gown

GUDID 00634916796780

Isolation gown, reusable

Primary Device ID	00634916796780
NIH Device Record Key	a1d231e8-44de-4e61-b9e6-a0e96b100a2a
Commercial Distribution Discontinuation	2023-02-28
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Isolation Gown
Version Model Number	661YUA15
Company DUNS	006999858
Company Name	STANDARD TEXTILE CO., 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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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	true

Device Issuing Agency	Device ID
GS1	00634916796780 [Primary]

OEA	Non-Surgical Isolation Gown

Steralize Prior To Use	false
Device Is Sterile	false

00634916796780	Isolation Gown, AAMI Level 2, Reusable, 100% Polyester, Tie Closures Neck and Waist, Raglan Slee
00634916790498	Isolation Gown, 3 Armhole, AAMI Level 1, Yellow, OSFA, Generic Polyester with Carbon, Wrap Aroun