FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient-Fitted TMJ Reconstructive Prosthesis System
DI: B0046520141
·
Model: 65-2014
·
TMJ Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Patient-Fitted TMJ Reconstructive Prosthesis System
- Primary DI
- B0046520141
- Version / Model
- 65-2014
- Company Name
- TMJ Solutions, Inc.
- Labeler DUNS
- 035877922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-01-27
- Public Version
- 6
- Public Version Date
- 2022-04-19
- Public Version Status
- Update
- Public Device Record Key
- 945298f2-27a9-4b6d-a92e-9c3caddb5ddd
Device Description
Bone Screw 2.0mm x 14mm, 5 Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| LZD | Joint, Temporomandibular, Implant | Dental | 872.3940 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36042 | Total temporomandibular joint prosthesis | A sterile artificial substitute for the temporomandibular joint (TMJ) implanted to treat patients with osteoarthritis, rheumatoid arthritis, congenital malformations, or neoplasms of the joint, as well as after trauma (e.g., fracture). It consists of mandibular condyle and mandibular fossa components implanted to functionally reconstruct the TMJ in the jaw. It is typically made of metal and/or polymeric materials. Fixation devices for implantation (e.g., screws) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B0046520141 | HIBCC | ||||
| Unit of Use | B0046120141 | HIBCC |
Customer Contacts
- Phone
- 805-650-3391
- [email protected]