FDA UDI
In Commercial Distribution
🇺🇸 United States
B-P TOTAL SHOULDER SYSTEM
DI: 00814193025463
·
Model: 02-04-0612
·
Synovo Production
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- B-P TOTAL SHOULDER SYSTEM
- Primary DI
- 00814193025463
- Version / Model
- 02-04-0612
- Catalog Number
- 02-04-0612
- Company Name
- Synovo Production
- Labeler DUNS
- 061486164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-17
- Public Version
- 5
- Public Version Date
- 2024-02-22
- Public Version Status
- Update
- Public Device Record Key
- a1cbd20c-0894-4452-8d1e-f736f49e6956
Device Description
B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 12 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
- 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 |
|---|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3650 | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | 888.3690 | 2 |
| MJT | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34162 | Bipolar humeral head outer component | An implantable, hemisphere-shaped component of a bipolar partial shoulder prosthesis designed to interface with the glenoid fossa on its outer surface where it freely rotates, and interface with a humeral head prosthesis on its inner surface where it allows free rotation of the head. It is typically composed of an outer metal shell and an inner polyethylene (PE) liner. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814193025463 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982418 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius