Identity
- Trade Name
- C-Thru FDA UDI
- Generic Name
- Orthopaedic operating table top FDA UDI
- Device Name
- C-Thru Infant SPICA Board - 3" x 36" (working surface approximately 10") FDA UDI
- Model / Reference
- C-Thru Infant Spica Board FDA UDI
- Description
- C-Thru Infant SPICA Board - 3" x 36" (working surface approximately 10") FDA UDI
Identifiers
- Catalog Number
- C-902715 FDA UDI
- Primary DI / UDI-DI
- 00810045920092 FDA UDI
- FDA Product Code
- FSE FDA UDI
- GMDN Term
- Orthopaedic operating table top FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic operating table top
C-Thru by Instrument Specialists, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ASSY, SPINAL TABLE TOP (500 LBS) REFURB. — Mizuho Orthopedic Systems, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- ORTHOPEDIC TRAUMA TOP (500#), REFURB. — Mizuho Orthopedic Systems, Inc. · Class I
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 |
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Manufacturer
- Manufacturer
- Instrument Specialists, Inc.
Sources (1)
- FDA UDI 471d32e8-1d68-4d10-bd35-ed3b08d166bb 34 fields · synced May 31, 2026