Identity
- Trade Name
- canturio™ te Modular Bracket, Impaction Sleeve FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. FDA UDI
- Model / Reference
- 110044505 FDA UDI
- Description
- CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015699108 FDA UDI
- 510(k) Number
- DEN200064 FDA UDI
- FDA Product Code
- QPP FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3600 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
canturio™ te Modular Bracket, Impaction Sleeve by Canary Medical Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN200064 also covers:
- canturio™te — CANARY MEDICAL USA LLC
- canturio™te Canary Tibial Ext 14x58mm X-Ray Template — CANARY MEDICAL USA LLC
- canturio™te Cemented Tibia Drill Bit — CANARY MEDICAL USA LLC
- canturio™te Impaction Sleeve — CANARY MEDICAL USA LLC
- canturio™te Modular Bracket Drill Bit — CANARY MEDICAL USA LLC
- canturio™te Modular Bracket Stem Provisional — CANARY MEDICAL USA LLC
- canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. — CANARY MEDICAL USA LLC
- canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. — CANARY MEDICAL USA LLC
- canturio™te Provisional — CANARY MEDICAL USA LLC
- canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. — CANARY MEDICAL USA LLC
- canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. — CANARY MEDICAL USA LLC
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
- Canary Medical Usa Llc
Sources (1)
- FDA UDI f90716c3-844b-4e1f-991c-8762ef002690 34 fields · synced May 30, 2026