FDA UDI
In Commercial Distribution
🇺🇸 United States
LATITUDE EV™
DI: 00846832074686
·
Model: 0030700
·
TORNIER, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LATITUDE EV™
- Primary DI
- 00846832074686
- Version / Model
- 0030700
- Catalog Number
- 0030700
- Company Name
- TORNIER, INC.
- Labeler DUNS
- 968990812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-12
- Public Version
- 3
- Public Version Date
- 2025-12-17
- Public Version Status
- Update
- Public Device Record Key
- 2c206743-8a72-42fa-8a45-0c89779551b2
Device Description
Humeral Stem - Coated
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 |
|---|---|---|---|---|
| JDC | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED | Orthopedic | 888.3150 | 2 |
| JDB | PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED | Orthopedic | 888.3160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33174 | Coated elbow humerus prosthesis | A sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846832074686 | GS1 |
Customer Contacts
- Phone
- +1(888)494-7950
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 72 | Millimeter | |
| Device Size Text, specify | Size SMALL |