FDA UDI
In Commercial Distribution
🇺🇸 United States
Redfield
DI: 00888937013283
·
Model: RIRC-LG6210
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Redfield
- Primary DI
- 00888937013283
- Version / Model
- RIRC-LG6210
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 0b29cb89-550b-4ebc-a6d6-adfcaf157adc
Device Description
6mm Dia. x 210mm Light Guide
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47758 | Infrared tissue coagulation system light guide | A detachable component of an infrared tissue coagulation system that is attached to the distal end of the system's handpiece and designed to transmit infrared (IR) light from the handpiece to blood vessels and soft tissues for haemostasis and/or tissue removal. The device is typically a rigid, flexible, or semi-flexible tube containing a fibreoptic core; it is available in various diameters and lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937013283 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974168 | 000 |