FDA UDI
In Commercial Distribution
🇺🇸 United States
Flow-Nail™
DI: B267101280
·
Model: 101-28
·
Flow-FX
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Flow-Nail™
- Primary DI
- B267101280
- Version / Model
- 101-28
- Catalog Number
- 101-28
- Company Name
- Flow-FX
- Labeler DUNS
- 079293587
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-08
- Public Version
- 1
- Public Version Date
- 2022-02-16
- Public Version Status
- New
- Public Device Record Key
- 2629b7a7-e072-4ba4-8111-638a69300e57
Device Description
FN Compression Nut
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 63995 | Femoral neck fracture compression tool component | A component of a multi-device tool designed for compression of a femoral neck fracture during the implantation of a fixation femoral neck, head nail, and/or screw. It consists of one of a variety of devices: a double threaded wire, a tubular housing instrument, or a manual nut for twisting/screwing to achieve the force required to compress the fracture. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B267101280 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140601 | 000 |