Identity
- Trade Name
- DISTRACTION, INTERNAL FDA UDI
- Generic Name
- Implantable craniofacial bone distractor FDA UDI
- Device Name
- DIST, MANDIBLE, ZURICH 2, RIGHT ANGLE, RIGHT, TI-6AL-4V FDA UDI
- Model / Reference
- 00-907-17-09 FDA UDI
- Description
- DIST, MANDIBLE, ZURICH 2, RIGHT ANGLE, RIGHT, TI-6AL-4V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888118032096 FDA UDI
- FDA Product Code
- MQN FDA UDI
- GMDN Term
- Implantable craniofacial bone distractor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Distraction, Internal by KLS-Martin L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- KLS-Martin L.P.
Sources (1)
- FDA UDI da6da552-d725-475b-9b9b-6d0fb7352cbc 36 fields · synced Jun 1, 2026