FDA UDI
In Commercial Distribution
🇺🇸 United States
Biocore9 Humeral Resurfacing System
DI: 00810068850024
·
Model: Humeral Resurfacing Component 48 mm
·
Biocore9, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Biocore9 Humeral Resurfacing System
- Primary DI
- 00810068850024
- Version / Model
- Humeral Resurfacing Component 48 mm
- Catalog Number
- 02-03-0048
- Company Name
- Biocore9, LLC
- Labeler DUNS
- 093081548
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-28
- Public Version
- 1
- Public Version Date
- 2021-10-06
- Public Version Status
- New
- Public Device Record Key
- b0d7ce02-b7bc-436f-ad90-6442ddd0d157
Device Description
Biocore9 Humeral Head Resurfacing Shoulder Component 48 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
- Yes
- 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 |
|---|---|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | 888.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48089 | Resurfacing humeral head prosthesis | A sterile implantable device designed to treat a disease-damaged (e.g., arthritic) shoulder joint by replacing the humeral articulating surface of the joint while preserving the natural humerus. It consists of a metallic humeral cap [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] that is placed over (resurfaces) a surgically-prepared humeral head, and may be used with a cementless stem. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810068850024 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193122 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 48 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius