FDA UDI
In Commercial Distribution
🇺🇸 United States
MUTARS® connecting part distal
DI: 04048844125349
·
Model: 5730010001
·
implantcast GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MUTARS® connecting part distal
- Primary DI
- 04048844125349
- Version / Model
- 5730010001
- Company Name
- implantcast GmbH
- Labeler DUNS
- 324369826
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-05
- Public Version
- 1
- Public Version Date
- 2019-04-15
- Public Version Status
- New
- Public Device Record Key
- 45440d6f-954d-45b2-bc5d-b401b7482faa
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 |
|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61560 | Sleeve femoral/tibial extension, uncoated | A sterile implantable device typically designed to be attached to a revision femoral stem prosthesis, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to compensate for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of uncoated metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Fixation devices for implantation (e.g., screws and bolts) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048844125349 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181778 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size: 100 mm |