Identity
- Trade Name
- OR Barcode Scanner FDA UDI
- Generic Name
- Patient health record information system FDA UDI
- Device Name
- After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components. FDA UDI
- Model / Reference
- 43-5570-006-14 FDA UDI
- Description
- After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015699016 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Patient health record information system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient health record information system
OR Barcode Scanner by Canary Medical Usa Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ELI Edit — MORTARA INSTRUMENT, INC. · Class II
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
- Canary Medical Usa Llc
Sources (1)
- FDA UDI b62da0e2-9c8e-499c-9df5-2ad7bebedfbf 33 fields · synced May 30, 2026