FDA UDI
Not in Commercial Distribution
🇺🇸 United States
2.0x6.0mm [1] & 2.0x8.0mm [4] Screws
DI: M9575001110
·
Model: 500111
·
Nexus Cmf, L.L.C.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 2.0x6.0mm [1] & 2.0x8.0mm [4] Screws
- Primary DI
- M9575001110
- Version / Model
- 500111
- Company Name
- Nexus Cmf, L.L.C.
- Labeler DUNS
- 965540227
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 6
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 9eb11e88-703c-4be2-bea7-395a49796451
- Distribution End Date
- 2017-05-31
Device Description
2.0x6.0mm [1] & 2.0x8.0mm [4] Screws
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MPI | Glenoid Fossa Prosthesis | Dental | 872.3950 | 3 |
| LZD | Joint, Temporomandibular, Implant | Dental | 872.3940 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46638 | Craniofacial bone screw, non-bioabsorbable | A small, threaded rod with a slotted head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M9575001110 | HIBCC |