FDA UDI
In Commercial Distribution
🇺🇸 United States
COMPREHENSIVE® SRS / NEXEL
DI: 00880304806016
·
Model: 110029825
·
Biomet Orthopedics, LLC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COMPREHENSIVE® SRS / NEXEL
- Primary DI
- 00880304806016
- Version / Model
- 110029825
- Catalog Number
- 110029825
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b2d4f2d8-227f-4313-acca-2f74bf18ee31
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
- MR Conditional
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDC | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED | Orthopedic | 888.3150 | 2 |
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3650 | 2 |
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| MBF | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED | Orthopedic | 888.3670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33702 | Uncoated elbow humerus prosthesis | A sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00880304806016 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153398 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 60 MM LEFT |