FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDPOR
DI: 07613252086598
·
Model: 9959
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDPOR
- Primary DI
- 07613252086598
- Version / Model
- 9959
- Catalog Number
- 9959
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 4
- Public Version Date
- 2020-10-12
- Public Version Status
- Update
- Public Device Record Key
- b484a42b-c158-4d17-a5ba-0a6fb8f6d565
Device Description
Mandibular Angle RZ Large - Left 11mm L.P.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FWP | PROSTHESIS, CHIN, INTERNAL | General, Plastic Surgery | 878.3550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35943 | Mandibular condyle prosthesis | A sterile implantable device designed to replace the natural mandibular condylar head, providing an articulation with the mandibular fossa and a partial substitution of the temporomandibular joint articulation. It is typically made of a combination of a metal frame and plastic (e.g., polymethylmethacrylate) or a combination of metal and polymeric materials. The device is almost always used in combination with mandibular fossa components in total temporomandibular joint (TMJ) prostheses. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613252086598 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922489 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 65.0 | Millimeter | |
| Height | 35.0 | Millimeter | |
| Device Size Text, specify | Thickness: 11.0 Millimeter |