Identity
- Trade Name
- Inoculation Loops FDA UDI
- Generic Name
- Inoculating tool IVD, manual FDA UDI
- Device Name
- HARD LOOP 10 µL STERILE, IN RESEALABLE BAGS OF 40 PCS FDA UDI
- Model / Reference
- 8177CSR40H FDA UDI
- Description
- HARD LOOP 10 µL STERILE, IN RESEALABLE BAGS OF 40 PCS FDA UDI
Identifiers
- Catalog Number
- 8177CSR40H FDA UDI
- Primary DI / UDI-DI
- 28053326004326 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Inoculating tool IVD, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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
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
Category: Inoculating tool IVD, manual
Inoculation Loops by Copan Italia Spa — 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
- Copan Italia Spa
Sources (1)
- FDA UDI 21d9dfaf-a226-4d6b-91e3-64f88c818c6b 34 fields · synced Jun 1, 2026