FDA UDI
In Commercial Distribution
🇺🇸 United States
REDFIELD CORPORATION
DI: 00888937013504
·
Model: IRC-HS1
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REDFIELD CORPORATION
- Primary DI
- 00888937013504
- Version / Model
- IRC-HS1
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-10
- Public Version
- 5
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- ba734024-7e21-4c0d-a13a-d8a2ff60cef1
Device Description
REDFIELD IRC 2100™
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 47754 | Infrared tissue coagulation system | An assembly of electrically-powered devices designed to produce infrared (IR) light used to heat blood vessels and soft tissues for haemostasis and/or tissue removal. It typically consists of a control unit, a handpiece, light guides, and contact tips. It may be used to stop bleeding, to remove superficial lesions (e.g., haemorrhoids, benign vaginal lesions, warts, tattoos), for tonsillectomy/adenotomy blood staunching, and to treat parenchymal or dental bleeding. The use of IR light helps to avoid/mimimize some adverse outcomes associated with the application of direct electrical current (e.g., electrode-tissue adhesions). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937013504 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974168 | 000 |