FDA UDI
In Commercial Distribution
🇺🇸 United States
Megasystem C
DI: 04026575352586
·
Model: 15-8502/66
·
WALDEMAR LINK GmbH & Co. KG
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Megasystem C
- Primary DI
- 04026575352586
- Version / Model
- 15-8502/66
- Catalog Number
- 15-8502/66
- Company Name
- WALDEMAR LINK GmbH & Co. KG
- Labeler DUNS
- 315675488
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5e4abcff-dd96-4bd6-a29a-fe4e79d7f3f5
Device Description
Stem Components,Support Ring for Stem Ø up to 18 mm
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
- Yes
- 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 |
|---|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | 888.3360 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | 888.3350 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | 888.3510 | 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 | 04026575352586 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151008 | 000 |