FDA UDI
In Commercial Distribution
🇺🇸 United States
Humeris Shoulder
DI: 03701037303252
·
Model: 316-0110
·
FX SOLUTIONS
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Humeris Shoulder
- Primary DI
- 03701037303252
- Version / Model
- 316-0110
- Catalog Number
- 316-0110
- Company Name
- FX SOLUTIONS
- Labeler DUNS
- 263076196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-22
- Public Version
- 4
- Public Version Date
- 2021-10-07
- Public Version Status
- Update
- Public Device Record Key
- c801856e-f4f6-4c74-9d41-b54fbd39ddb2
Device Description
HUMERIS STEM TA6V SIZE 10 CEMENTED
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
- No
- 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 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34197 | Uncoated shoulder humeral stem prosthesis | A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701037303252 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163669 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | SIZE 10 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light and sunlight Store away from moisture