FDA UDI Not in Commercial Distribution 🇺🇸 United States

MAMMOGRAM CAPE

DI: 00634916307948 · Model: 74V96081 · STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
48

Basic Information

Brand Name
MAMMOGRAM CAPE
Primary DI
00634916307948
Version / Model
74V96081
Catalog Number
74V96081
Company Name
STANDARD TEXTILE CO., INC.
Labeler DUNS
006999858
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
48
Record Status
Published
Publish Date
2018-01-29
Public Version
3
Public Version Date
2023-07-03
Public Version Status
Update
Public Device Record Key
1565b6e5-f5c3-44b4-a305-9e17abd8cf7a
Distribution End Date
2018-01-29

Device Description

MAMMOGRAM CAPE KAUM NOVA PINK OSFA RM (98 8336) USE: 74953081

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
FME Gown, Examination

GMDN Terms

Code Name
11905 Patient gown, reusable

Identifiers

Type ID
Primary 00634916307948
Unit of Use 10634916307948

Customer Contacts