FDA UDI In Commercial Distribution 🇺🇸 United States

Ankle Compression Nailing System

DI: 18033509858352 · Model: 1 · ORTHOFIX SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ankle Compression Nailing System
Primary DI
18033509858352
Version / Model
1
Catalog Number
99-T770250
Company Name
ORTHOFIX SRL
Labeler DUNS
438793622
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-01
Public Version
4
Public Version Date
2023-09-18
Public Version Status
Update
Public Device Record Key
c8d8fe31-98cb-4a94-960a-b2870cd9079b

Device Description

TITANIUM ANKLE COMPRESSION NAIL 10/250

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
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
JDS Nail, Fixation, Bone
HSB Rod, Fixation, Intramedullary And Accessories

GMDN Terms

Code Name
44854 Arthrodesis nail, fixed-length

Identifiers

Type ID
Primary 18033509858352

Customer Contacts

Device Sizes

Type Value Unit Text
Length 250 Millimeter
Outer Diameter 10 Millimeter