FDA UDI
In Commercial Distribution
🇺🇸 United States
20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Nidek
DI: 10817489023591
·
Model: V6300-20ER
·
KATALYST SURGICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Nidek
- Primary DI
- 10817489023591
- Version / Model
- V6300-20ER
- Company Name
- KATALYST SURGICAL LLC
- Labeler DUNS
- 007883297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-11-27
- Public Version
- 1
- Public Version Date
- 2020-12-07
- Public Version Status
- New
- Public Device Record Key
- b0bc9116-dbe0-422d-9cc9-38afc7a9265d
Device Description
20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Nidek
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45193 | Ophthalmic fibreoptic light instrument, single-use | A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00817489023594 | GS1 | ||||
| Primary | 10817489023591 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121187 | 000 |