FDA UDI
In Commercial Distribution
🇺🇸 United States
Apex
DI: 05391529587697
·
Model: F05-850380
·
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Apex
- Primary DI
- 05391529587697
- Version / Model
- F05-850380
- Catalog Number
- F05-850380
- Company Name
- ORTHOXEL DESIGNATED ACTIVITY COMPANY
- Labeler DUNS
- 985596830
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-07
- Public Version
- 1
- Public Version Date
- 2023-07-17
- Public Version Status
- New
- Public Device Record Key
- 55e2c217-397a-4595-9464-b321fe20a416
Device Description
Apex Femoral Nail Retrograde Ø 8.5 x 380mm
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 | 05391529587697 | GS1 |
Customer Contacts
- Phone
- 646-661-3167
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181375 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Ø 8.5 x 380mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Ambient Storage and Handling