FDA UDI
In Commercial Distribution
🇺🇸 United States
Talon™ DistalFix™ A/R Femoral Nail
DI: B058ART113401
·
Model: ART11340
·
Orthopedic Designs North America, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Talon™ DistalFix™ A/R Femoral Nail
- Primary DI
- B058ART113401
- Version / Model
- ART11340
- Catalog Number
- ART-11-340
- Company Name
- Orthopedic Designs North America, Inc.
- Labeler DUNS
- 945518848
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-29
- Public Version
- 2
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 51a544d5-9861-4c47-9553-b1ea717bd78a
Device Description
Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 340mm
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33187 | Femur nail | A rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B058ART113401 | HIBCC |
Customer Contacts
- Phone
- 888-635-8535
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152295 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 11 | Millimeter | |
| Length | 340 | Millimeter |