FDA UDI In Commercial Distribution 🇺🇸 United States

Fixion Nailing System

DI: 07290109331096 · Model: Tibial Nail Cap · CARBOFIX ORTHOPEDICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Fixion Nailing System
Primary DI
07290109331096
Version / Model
Tibial Nail Cap
Catalog Number
9220900
Company Name
CARBOFIX ORTHOPEDICS LTD
Labeler DUNS
649185170
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-10-15
Public Version
4
Public Version Date
2021-04-07
Public Version Status
Update
Public Device Record Key
4a405105-63ec-40f9-a864-df42ecaaf5a2

Device Description

Nail cap for Fixion interlocking intramedullary tibial nails.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HSB Rod, Fixation, Intramedullary And Accessories

GMDN Terms

Code Name
46139 Bone nail end-cap

Identifiers

Type ID
Primary 07290109331096