FDA UDI In Commercial Distribution 🇺🇸 United States

Standard Supreme Drape

DI: 00634916091052 · Model: 95560562 · STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24

Basic Information

Brand Name
Standard Supreme Drape
Primary DI
00634916091052
Version / Model
95560562
Catalog Number
95560562
Company Name
STANDARD TEXTILE CO., INC.
Labeler DUNS
006999858
Distribution Status
In Commercial Distribution
Device Count in Pkg
24
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
84260716-72f2-4c8f-a2e7-fd2ec8317f71

Device Description

SPINAL DRAPE SHEET STANDARD SUPREME MISTY 28X32 - 2PLY STD SUP W/3X3 BND FEN

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 00634916091052
Unit of Use 10634916091059

Customer Contacts