Identity
- Trade Name
- Redfield FDA UDI
- Generic Name
- Infrared tissue coagulation system light guide FDA UDI
- Device Name
- 3mm dia. x 90mm Light Guide FDA UDI
- Model / Reference
- RIRC-LG390 FDA UDI
- Description
- 3mm dia. x 90mm Light Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937013269 FDA UDI
- 510(k) Number
- K974168 FDA UDI
- FDA Product Code
- KNS FDA UDI
- GMDN Term
- Infrared tissue coagulation system light guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared tissue coagulation system light guide
Redfield by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared tissue coagulation system light guide.
- Redfield — CooperSurgical, Inc. · Class II
- Redfield — CooperSurgical, Inc. · Class II
Cleared under the same submission
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 62cdcd0f-6c54-4fce-baaa-d6f471482aa1 34 fields · synced Jun 9, 2026