FDA UDI
In Commercial Distribution
🇺🇸 United States
Tornier HRS Max
DI: 00840338603586
·
Model: ARS10407100
·
TORNIER, INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tornier HRS Max
- Primary DI
- 00840338603586
- Version / Model
- ARS10407100
- Catalog Number
- ARS10407100
- Company Name
- TORNIER, INC.
- Labeler DUNS
- 968990812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-19
- Public Version
- 1
- Public Version Date
- 2025-11-27
- Public Version Status
- New
- Public Device Record Key
- aa1cbdc2-25e7-42ad-b0da-3742fd2c7691
Device Description
Spacer
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | Orthopedic | 888.3690 | 2 |
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| 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 |
|---|---|---|---|---|
| 60933 | Humeral body extension prosthesis | A sterile implantable component of a reverse shoulder prosthesis that consists of a metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] piece intended to function as a spacer between a reverse shoulder body prosthesis and a reverse shoulder cup prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840338603586 | GS1 |
Customer Contacts
- Phone
- +1(888)494-7950
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251686 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 100 | Millimeter | |
| Device Size Text, specify | Size: 100 |