FDA UDI
In Commercial Distribution
🇺🇸 United States
Aequalis™ Adjustable Reversed
DI: 00846832060283
·
Model: 6501350
·
TORNIER, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aequalis™ Adjustable Reversed
- Primary DI
- 00846832060283
- Version / Model
- 6501350
- Catalog Number
- 6501350
- Company Name
- TORNIER, INC.
- Labeler DUNS
- 968990812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 4
- Public Version Date
- 2022-03-25
- Public Version Status
- Update
- Public Device Record Key
- 36df017d-5bbb-46f6-89ce-4591459d8b10
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61002 | Humeral head spacer | A sterile implantable component of a total shoulder prosthesis intended to be placed between a standard humeral body and a standard humeral head to serve as a spacer and to achieve the intended varus/valgus alignment. It is in the form of a thick disc with a central or eccentric hole, is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)], and is used in a modular shoulder replacement system. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846832060283 | GS1 |
Customer Contacts
- Phone
- +1(888)494-7950
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 13 | Millimeter | |
| Length | 50 | Millimeter |