Identity
- Trade Name
- IPS FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model FDA UDI
- Device Name
- MODEL, ILIAC CREST, PA FDA UDI
- Model / Reference
- 60-500-52-09 FDA UDI
- Description
- MODEL, ILIAC CREST, PA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888118124166 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Custom-made organ/bone anatomy model
Ips by KLS-Martin L.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made organ/bone anatomy model.
- Cadence Chamfer Cut Total Ankle System — 3D SYSTEMS, INC. · Class II
- Match Point System — Materialise NV · Class II
- ProPlan CMF — Materialise NV · Class I
- ProPlan CMF — Materialise NV · Class I
- ProPlan CMF — Materialise NV · Class I
- Vantage 3D PSI — 3D SYSTEMS, INC. · Class II
- Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, LLC · Class III
- Treatment Plan Rhinoplasty Model — Mirrorme3D, LLC · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KLS-Martin L.P.
Sources (1)
- FDA UDI b32cb9e3-2b0d-4b4d-a01c-6fe8b7fe1491 34 fields · synced May 31, 2026