Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Integra® Titanium Bone Wedge System The Cotton Wedge Trial Caddy Lid is the top part of the caddy which locked onto the base and keeps content inside the base. FDA UDI
- Model / Reference
- CSA-1006-05 FDA UDI
- Description
- Integra® Titanium Bone Wedge System The Cotton Wedge Trial Caddy Lid is the top part of the caddy which locked onto the base and keeps content inside the base. FDA UDI
Identifiers
- Catalog Number
- CSA100605 FDA UDI
- Primary DI / UDI-DI
- 10381780247968 FDA UDI
- FDA Product Code
- OJH FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
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Serial Number
No
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Expiration Date
Yes
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Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Integra® by Ascension Orthopedics, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 59fe9ed4-de7a-4e39-a199-8eb8fa0b0cff 37 fields · synced May 30, 2026