FDA UDI In Commercial Distribution 🇺🇸 United States

Standard Supreme Drape

DI: 00634916005356 · Model: 95280222 · STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36

Basic Information

Brand Name
Standard Supreme Drape
Primary DI
00634916005356
Version / Model
95280222
Catalog Number
95280222
Company Name
STANDARD TEXTILE CO., INC.
Labeler DUNS
006999858
Distribution Status
In Commercial Distribution
Device Count in Pkg
36
Record Status
Published
Publish Date
2018-01-29
Public Version
3
Public Version Date
2023-07-27
Public Version Status
Update
Public Device Record Key
3cd0bde9-e92c-43fc-a408-05957e3b8cc3

Device Description

PERI SHEET STD SUPREME 49X70 - 1PLY STD S W/REIN-CO

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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
PUI Drape, Surgical, Exempt

GMDN Terms

Code Name
47780 Patient surgical drape, reusable

Identifiers

Type ID
Primary 00634916005356
Unit of Use 10634916005353

Customer Contacts