FDA UDI In Commercial Distribution 🇺🇸 United States

9'' DUAL ADJUSTMENT BACK SUP

DI: 00609271051379 · Model: 232-0010-50 · DARCO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
9'' DUAL ADJUSTMENT BACK SUP
Primary DI
00609271051379
Version / Model
232-0010-50
Catalog Number
232-0010-50
Company Name
DARCO INTERNATIONAL, INC.
Labeler DUNS
184231298
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-08
Public Version
1
Public Version Date
2023-02-16
Public Version Status
New
Public Device Record Key
870c0043-496c-44ee-84b6-e4a8b74422dc

Device Description

Large

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IPY ORTHOSIS, LUMBO-SACRAL

GMDN Terms

Code Name
33031 Lumbar spine orthosis

Identifiers

Type ID
Package 20609271051373
Primary 00609271051379
Package 10609271051376