FDA UDI
In Commercial Distribution
🇺🇸 United States
TFN-ADVANCE
DI: 10886982097286
·
Model: 04.037.244S
·
Synthes GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- TFN-ADVANCE
- Primary DI
- 10886982097286
- Version / Model
- 04.037.244S
- Catalog Number
- 04037244S
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 6
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- cc50e0f2-8668-44e7-9125-ff2ab0f9bc9c
Device Description
12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
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
- 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 intramedullary nail | A rigid 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 is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). 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 |
|---|---|---|---|---|---|---|
| Secondary | H67904037244S0 | HIBCC | ||||
| Primary | 10886982097286 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]