FDA UDI In Commercial Distribution 🇺🇸 United States

BUCKS TRACTION w/LINER

DI: 00609271080607 · Model: 872-0012-10 · DARCO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
BUCKS TRACTION w/LINER
Primary DI
00609271080607
Version / Model
872-0012-10
Catalog Number
872-0012-10
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
80543bfd-64a4-4b4a-9c60-42b9783389da

Device Description

Universal

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
HSP SPLINT, TRACTION

GMDN Terms

Code Name
66444 Lower-limb orthosis ankle/foot component

Identifiers

Type ID
Package 10609271080604
Primary 00609271080607
Package 20609271080601