FDA UDI
In Commercial Distribution
🇺🇸 United States
Humelock Reversed System
DI: 03701037309483
·
Model: 105-3211
·
FX SOLUTIONS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Humelock Reversed System
- Primary DI
- 03701037309483
- Version / Model
- 105-3211
- Catalog Number
- 105-3211
- Company Name
- FX SOLUTIONS
- Labeler DUNS
- 263076196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-26
- Public Version
- 1
- Public Version Date
- 2024-03-05
- Public Version Status
- New
- Public Device Record Key
- 8a1daf58-5b19-4767-b2e8-b09bdbf9ceb4
Device Description
HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36259 | Shoulder glenoid fossa prosthesis, prefabricated | An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701037309483 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192206 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 32 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light and sunlight Store away from moisture