FDA UDI
Not in Commercial Distribution
🇺🇸 United States
B-P TOTAL SHOULDER SYSTEM
DI: 00814193024992
·
Model: 02-02-0248
·
ENDOTEC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- B-P TOTAL SHOULDER SYSTEM
- Primary DI
- 00814193024992
- Version / Model
- 02-02-0248
- Catalog Number
- 02-02-0248
- Company Name
- ENDOTEC, INC.
- Labeler DUNS
- 803488357
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-17
- Public Version
- 6
- Public Version Date
- 2024-04-10
- Public Version Status
- Update
- Public Device Record Key
- cb71f6b6-c3fb-4a0a-841d-39bd98d45942
- Distribution End Date
- 2024-03-04
Device Description
B-P SHOULDER GLENOID BEARING SIZE 2, 0 MM THICKNESS, 48 MM HUMERAL HEAD
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 |
|---|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35670 | Total shoulder prosthesis | A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814193024992 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904879 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 48 | Millimeter | |
| Width | 0 | Millimeter | |
| Device Size Text, specify | SIZE 2 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius