FDA UDI
In Commercial Distribution
🇺🇸 United States
25ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex Connector
DI: 10817489027674
·
Model: V6351-25AR
·
KATALYST SURGICAL LLC
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- 25ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex Connector
- Primary DI
- 10817489027674
- Version / Model
- V6351-25AR
- Company Name
- KATALYST SURGICAL LLC
- Labeler DUNS
- 007883297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-04-03
- Public Version
- 1
- Public Version Date
- 2019-04-11
- Public Version Status
- New
- Public Device Record Key
- 6fd034d7-671f-42ba-b566-318df3430c01
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MPA | Endoilluminator | Gastroenterology, Urology | 876.1500 | 2 |
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
| HQB | Photocoagulator And Accessories | Ophthalmic | 886.4690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61162 | Ophthalmic laser system beam guide | A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10817489027674 | GS1 | ||||
| Unit of Use | 00817489027677 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121187 | 000 |