Identity
- Trade Name
- 5 x10mm CitreLock Xpress Implant Kit FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
- Model / Reference
- 70-812-0510 FDA UDI
Identifiers
- Catalog Number
- 70-812-0510 FDA UDI
- Primary DI / UDI-DI
- 00810027270306 FDA UDI
- FDA Product Code
- HWC FDA UDIMAI FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tendon/ligament bone anchor, bioabsorbableOrthopaedic inorganic implant inserter/extractor, single-use
5 x10mm CitreLock Xpress Implant Kit by Acuitive Technologies — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Acuitive Technologies
Sources (1)
- FDA UDI 6aa25232-0a8f-466f-8ec7-06fe8e7db23f 34 fields · synced Jun 1, 2026