FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lone Star® IRI Delivery
DI: 00888937018240
·
Model: IRI-DTD
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lone Star® IRI Delivery
- Primary DI
- 00888937018240
- Version / Model
- IRI-DTD
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-21
- Public Version
- 2
- Public Version Date
- 2025-07-28
- Public Version Status
- Update
- Public Device Record Key
- ee90e09d-0a19-4b6b-95bf-c5c9313d4b25
- Distribution End Date
- 2025-07-25
Device Description
Lone Star® IRI Delivery Tube Replacement
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
- 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 |
|---|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | 876.4730 | 1 |
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 | 00888937018240 | GS1 |