FDA UDI
In Commercial Distribution
🇺🇸 United States
Hintermann Series H2
DI: 00841731141996
·
Model: HT-31823
·
VILEX LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hintermann Series H2
- Primary DI
- 00841731141996
- Version / Model
- HT-31823
- Company Name
- VILEX LLC
- Labeler DUNS
- 117502293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-05
- Public Version
- 1
- Public Version Date
- 2025-09-15
- Public Version Status
- New
- Public Device Record Key
- df723bb1-5b9c-43c8-99df-bb9bd21c1c84
Device Description
Hintermann Series H2 Tibia Implant, Sz3 Right, 9.5mm
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | Orthopedic | 888.3110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 39704 | Coated ankle tibia prosthesis | A sterile implantable device designed to replace the distal tibia (tibial component) as part of a primary ankle joint replacement or prosthesis revision. 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 | 00841731141996 | GS1 |
Customer Contacts
- Phone
- +1(800)521-5002
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240475 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 9.5mm 3 RIGHT |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place.