FDA UDI
In Commercial Distribution
🇺🇸 United States
Joint Shim
DI: M9703400160000
·
Model: 3400-16-000
·
Medshape, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Joint Shim
- Primary DI
- M9703400160000
- Version / Model
- 3400-16-000
- Company Name
- Medshape, Inc.
- Labeler DUNS
- 601306413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-19
- Public Version
- 1
- Public Version Date
- 2023-05-29
- Public Version Status
- New
- Public Device Record Key
- 98fb8174-d848-41ae-a59a-319c6318f030
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63917 | Orthopaedic bone fixation plate spacer | A small, non-sterile, threaded implantable device intended to be used to maintain a space between an orthopaedic bone fixation plate and the bone to which the plate is fixed, to reduce complications of impaired blood flow in the periosteum. It is made of metal and is screwed into an empty screw hole, producing a short projection on the inside of the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M9703400160000 | HIBCC |