Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- Integra® Total Foot System Cup Spherical Reamer Sz. 21mm The Cup cannulated reamer is intended for preparing the MTP joint for fusion and providing an accurate anatomic fit. FDA UDI
- Model / Reference
- CCR8950121 FDA UDI
- Description
- Integra® Total Foot System Cup Spherical Reamer Sz. 21mm The Cup cannulated reamer is intended for preparing the MTP joint for fusion and providing an accurate anatomic fit. FDA UDI
Identifiers
- Catalog Number
- CCR-895-01-21 FDA UDI
- Primary DI / UDI-DI
- 10381780242741 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-resection orthopaedic reamer, reusable
Integra® by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 40b0a041-dc8d-48ad-b212-fdd38280ea4f 37 fields · synced May 30, 2026