FDA UDI In Commercial Distribution 🇺🇸 United States

Precaution Gown

DI: 00634916708080 · Model: 66124385 · STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
48

Basic Information

Brand Name
Precaution Gown
Primary DI
00634916708080
Version / Model
66124385
Catalog Number
66124385
Company Name
STANDARD TEXTILE CO., INC.
Labeler DUNS
006999858
Distribution Status
In Commercial Distribution
Device Count in Pkg
48
Record Status
Published
Publish Date
2020-04-03
Public Version
1
Public Version Date
2020-04-13
Public Version Status
New
Public Device Record Key
bd8121f6-75ea-41f0-919e-86d2a9fe44d5

Device Description

Generic Polyester Precaution Gown, Bound Neck With Adjustable Snap Closure, Long Sleeves With White Poly Cuffs, Size XL

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OEA Non-Surgical Isolation Gown

GMDN Terms

Code Name
35452 Isolation gown, reusable

Identifiers

Type ID
Primary 00634916708080
Unit of Use 10634916708087

Customer Contacts