25ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Quantel
- Primary DI
- 00817489023686
- Brand
- 25ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Quantel
- Company
- KATALYST SURGICAL LLC
- Model
- V6300-25CR
- Device description
- 25ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Quantel
- Published
- 2020-11-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HQF | Laser, Ophthalmic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HQF | Laser, Ophthalmic | Ophthalmic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K121187 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10817489023683 | Primary | GS1 | 0 | |
| 00817489023686 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10817489023683 | 10817489023683 | ||
| 00817489023686 | 00817489023686 | 817489023686 | 0817489023686 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 007883297
- Device count
- 10
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 10840096211365 | Cili Probes (Cyclophotocoagulation) | 620231 | 2020-03-04 | |
| 10817489025298 | Cyclophotocoagulation Probe, Quantel Connector | XLCYCLO | 2018-12-11 | |
| 10817489025304 | Cyclophotocoagulation Probe, Iridex Connector | XLCYCLOA | 2018-12-11 | |
| 10817489025151 | Ciliprobe Transsceral Cyclophotocoagulation Probe | D4700A | 2017-07-21 | |
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| 10817489023577 | 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Alcon | V6300-20BR | 2020-11-27 | |
| 10817489023584 | 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Quantel | V6300-20CR | 2020-11-27 | |
| 10817489023591 | 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Nidek | V6300-20ER | 2020-11-27 | |
| 10817489023607 | 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORC | V6300-20JR | 2020-11-27 | |
| 10817489023614 | 23ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex | V6300-23AR | 2020-11-25 | |
| 10817489023621 | 23ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Alcon | V6300-23BR | 2020-11-27 | |
| 10817489023638 | 23ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Quantel | V6300-23CR | 2020-11-27 | |
| 10817489023645 | 23ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Nidek | V6300-23ER | 2020-11-27 |
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