FDA UDI
In Commercial Distribution
🇺🇸 United States
Comprehensive® SRS Instrument
DI: 00887868503573
·
Model: 405123
·
Biomet Orthopedics, LLC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Comprehensive® SRS Instrument
- Primary DI
- 00887868503573
- Version / Model
- 405123
- Catalog Number
- 405123
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-05
- Public Version
- 2
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- bb33a290-f91d-4adf-b1f9-84150b23e3a7
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| JDC | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED | Orthopedic | 888.3150 | 2 |
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3650 | 2 |
| MBF | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED | Orthopedic | 888.3670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60936 | Humeral stem prosthesis trial, reusable | A copy of a final humeral stem prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is typically made of metal and/or synthetic polymer. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887868503573 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111746 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10 mm X 100 mm |