25ga Illuminated MultiFlex™ Laser Probe, DORC Connector
- Primary DI
- 00840096213959
- Brand
- 25ga Illuminated MultiFlex™ Laser Probe, DORC Connector
- Company
- KATALYST SURGICAL LLC
- Model
- V6351-25JR
- Device description
- 25ga Illuminated MultiFlex™ Laser Probe, DORC Connector
- Published
- 2021-01-07
- 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 |
|---|---|
| MPA | Endoilluminator |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MPA | Endoilluminator | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K121187 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10840096213956 | Primary | GS1 | 0 | |
| 00840096213959 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10840096213956 | 10840096213956 | ||
| 00840096213959 | 00840096213959 | 840096213959 | 0840096213959 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
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 |
|---|---|---|---|---|
| 10817489026301 | 25ga DEX™ Slim Morris ILM Forceps | DVFO4033-25 | DVFO4033-25 | 2020-09-21 |
| 10817489026318 | 27ga DEX™ Stiff Slim Morris ILM Forceps | DVFO4033-27 | DVFO4033-27 | 2020-09-21 |
| 10817489027148 | 23ga DEX™ Hassan Forceps | DVF4035-23 | DVF4035-23 | 2020-11-01 |
| 10817489027162 | 27ga DEX Stiff Hassan Forceps | DVF4035-27 | DVF4035-27 | 2020-11-01 |
| 10817489027315 | 23ga Slim DEX™ Hassan Forceps | DVFO4035-23 | DVFO4035-23 | 2020-09-21 |
| 10817489027322 | 25ga Slim DEX™ Hassan Forceps | DVFO4035-25 | DVFO4035-25 | 2020-09-21 |
| 10817489027339 | 27ga Stiff Slim DEX™ Hassan Forceps | DVFO4035-27 | DVFO4035-27 | 2020-09-21 |
| 10817489027353 | 27ga Slim DEX™ Vertical Scissors | DVSO5101-27 | 2020-11-01 | |
| 10817489027391 | 23ga MultiFlex Laser Probe, Iridex Compatible | XLEND23MULTIFLEXA | XLEND23MULTIFLEXA | 2018-11-26 |
| 10840096211044 | 23ga Slim DEX™ Super Grip II Forceps | DVFO4036-23 | DVFO4036-23 | 2020-09-21 |
| 10840096211105 | 25ga Slim DEX™ Super Grip II Forceps | DVFO4036-25 | DVFO4036-25 | 2020-09-21 |
| 10840096211112 | 27ga Stiff Slim DEX™ Super Grip II Forceps | DVFO4036-27 | DVFO4036-27 | 2020-09-21 |
| 10840096211174 | 25ga Stiff DEX™ Yoneda Super Grip Forceps | DVF4036-25-S | DVF4036-25-S | 2020-11-01 |
| 10840096212898 | 23ga DEX™ EZPeel Forceps | DVF4037-23 | DVF4037-23 | 2020-07-06 |
| 10840096212904 | 25ga DEX™ EZPeel Forceps | DVF4037-25 | DVF4037-25 | 2020-07-06 |
| 10840096212911 | 27ga DEX™ EZPeel Forceps | DVF4037-27 | DVF4037-27 | 2020-07-06 |
| 10840096212928 | 25ga Stiff DEX™ EZPeel Forceps | DVF4037-25-S | DVF4037-25-S | 2020-07-06 |
| 10840096212935 | 23ga Slim DEX™ EZPeel Forceps | DVFO4037-23 | DVFO4037-23 | 2020-07-06 |
| 10840096212942 | 25ga Slim DEX™ EZPeel Forceps | DVFO4037-25 | DVFO4037-25 | 2020-07-06 |
| 10840096212959 | 25ga Slim Stiff DEX™ EZPeel Forceps | DVFO4037-25-S | DVFO4037-25-S | 2020-07-06 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00893872001653 | iTrack 250E | Nova Eye, Inc. | MPA | 2026-05-05 |
| 00817325025010 | iChopper | MEDIMAX TECH INC. | MPA | 2026-04-30 |
| 00893872001684 | iTrack Advance | Nova Eye, Inc. | MPA | 2026-04-15 |
| 00893872001660 | iLumin | Nova Eye, Inc. | MPA | 2026-01-09 |
| 00840096215304 | XLEND23MULTIFLEX | KATALYST SURGICAL LLC | MPA | 2025-06-24 |
| 00840096215311 | XLEND25MULTIFLEX | KATALYST SURGICAL LLC | MPA | 2025-06-24 |
| 00810123483648 | Vortex Surgical Inc. | Vortex Surgical, Inc. | MPA | 2025-04-19 |
| 00810123483617 | Vortex Surgical Inc. | Vortex Surgical, Inc. | MPA | 2025-04-18 |
| 00810123483624 | Vortex Surgical Inc. | Vortex Surgical, Inc. | MPA | 2025-04-18 |
| 00810123483631 | Vortex Surgical Inc. | Vortex Surgical, Inc. | MPA | 2025-04-18 |
| 08717872035499 | TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-04-01 |
| 08717872035543 | TotalView Chandelier for cannula system.(25 gauge / 0.5 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-04-01 |
| 18717872035496 | TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-04-01 |
| 18717872035540 | TotalView Chandelier for cannula system.(25 gauge / 0.5 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-04-01 |
| 08717872035406 | Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035420 | 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035444 | Shielded TotalView Endoillumination Probe, including illuminated scleral depress | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035451 | TotalView Endoillumination Probe, including illuminated scleral depressor.(23 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035468 | TotalView Endoillumination Probe, including illuminated scleral depressor.(25 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035475 | Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035482 | Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035505 | TotalView Endoillumination Probe, including illuminated scleral depressor.(20 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035512 | Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035529 | Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gauge | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035550 | Disposable Chandelier fiber (one fiber) with Photon connector and guidance needl | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035567 | Spaide TotalView Endoillumination Probe, including illuminated scleral depressor | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035581 | TotalView Chandelier for Eckardt cannula system.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 08717872035598 | Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge / | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 18717872035403 | Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |
| 18717872035427 | 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | MPA | 2025-03-31 |