FDA UDI
In Commercial Distribution
🇺🇸 United States
Tornier Perform Humeral System
DI: 00846832094202
·
Model: ARS1022303
·
TORNIER, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tornier Perform Humeral System
- Primary DI
- 00846832094202
- Version / Model
- ARS1022303
- Catalog Number
- ARS1022303
- Company Name
- TORNIER, INC.
- Labeler DUNS
- 968990812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-16
- Public Version
- 1
- Public Version Date
- 2024-12-24
- Public Version Status
- New
- Public Device Record Key
- e184f84d-88f7-4599-aaad-84761b7d4b5a
Device Description
VE Reversed Insert, 45%
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| PHX | shoulder prosthesis, reverse configuration | Orthopedic | 888.3660 | 2 |
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | Orthopedic | 888.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48092 | Polyethylene reverse shoulder prosthesis cup | A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846832094202 | GS1 |
Customer Contacts
- Phone
- +1(888)494-7950
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241878 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 42 | Millimeter | |
| Device Size Text, specify | Thickness -2 mm | ||
| Device Size Text, specify | Size: 3 / 4 |