27ga Stiff MultiFlex Extendable Laser Probe, Nidek Connector
- Primary DI
- 00840096213270
- Brand
- 27ga Stiff MultiFlex Extendable Laser Probe, Nidek Connector
- Company
- KATALYST SURGICAL LLC
- Model
- V6510E-27E
- Device description
- 27ga Stiff MultiFlex Extendable Laser Probe, Nidek Connector
- Published
- 2020-10-26
- 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 |
|---|---|---|---|---|
| 10840096213277 | Primary | GS1 | 0 | |
| 00840096213270 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10840096213277 | 10840096213277 | ||
| 00840096213270 | 00840096213270 | 840096213270 | 0840096213270 |
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
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10817489027483 | Laser Probe OS4, MultiFlex, 23ga | VK400303 | 2019-03-19 | |
| 10817489027490 | Laser Probe OS4, MultiFlex, 25ga | VK400305 | 2019-03-19 | |
| 10817489027506 | Laser Probe OS4, MultiFlex Inverted, 23ga | VK400313 | 2019-03-19 | |
| 10817489027513 | Laser Probe OS4, MultiFlex Inverted, 25ga | VK400315 | 2019-03-19 | |
| 10817489027520 | Laser Probe OS4, MultiFlex Extendable, 23ga | VK400323 | 2019-03-19 | |
| 10817489027544 | Laser Probe OS4, MultiFlex Inverted Extendable, 23ga | VK400333 | 2019-03-19 | |
| 10817489027551 | Laser Probe OS4, MultiFlex Inverted Extendable, 25ga | VK400335 | 2019-03-19 | |
| 10840096211235 | 20ga Straight Laser Probe | 620200 | 2020-03-04 | |
| 10840096211242 | 23ga Straight Laser Probe | 620201 | 2020-03-04 | |
| 10840096211259 | 25ga Straight Laser Probe | 620202 | 2020-03-04 | |
| 10840096211266 | 27ga Straight Laser Probe | 620203 | 2020-03-04 | |
| 10840096211273 | 23ga Flexible Curved Laser Probe | 620210 | 2020-03-04 | |
| 10840096211280 | 25ga Flexible Curved Laser Probe | 620211 | 2020-03-04 | |
| 10840096211297 | 27ga Flexible Curved Laser Probe | 620212 | 2020-03-04 | |
| 10840096211303 | 20ga Illuminated Straight Laser Probe | 620220 | 2020-03-04 | |
| 10840096211310 | 23ga Illuminated Straight Laser Probe | 620221 | 2020-03-04 | |
| 10840096211327 | 25ga Illuminated Straight Laser Probe | 620222 | 2020-03-04 | |
| 10840096211334 | 27ga Illuminated Straight Laser Probe | 620223 | 2020-03-04 | |
| 10840096211341 | 23ga Illuminated Flexible Curved Laser Probe | 620229 | 2020-03-04 | |
| 10840096211358 | 25ga Illuminated Flexible Curved Laser Probe | 620230 | 2020-03-04 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
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| 08717872014142 | Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 2022-07-01 |
| 08717872014173 | Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 2022-07-01 |
| 08717872014203 | Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 2022-07-01 |
| 08717872014968 | Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 2022-07-01 |
| 08717872014975 | Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 2022-07-01 |
| 08717872014982 | Directional Laser Probe with DORC connector.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 2022-07-01 |
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| 08717872031897 | Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 2022-07-01 |
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