25ga Illuminated MultiFlex™ Laser Probe, DORC Connector
- Primary DI
- 10840096213956
- 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
- Update
- Distribution status
- Not 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. |
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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|---|---|---|---|---|
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| 00817489025413 | 23ga DEX™ Morris ILM Forceps | DVF4033-23 | DVF4033-23 | 2026-10-07 |
| 00840096202601 | 27ga DEX™ Yoneda Super Grip Forceps | DVF4036-27 | DVF4036-27 | 2026-10-07 |
| 00840096203608 | 23ga DEX™ Yoneda Super Grip Forceps | DVF4036-23 | DVF4036-23 | 2026-10-07 |
| 00840096203615 | 25ga DEX™ Yoneda Super Grip Forceps | DVF4036-25 | DVF4036-25 | 2026-10-07 |
| 00840096205091 | 25ga DEX Stiff NanoTapered Awh Forceps | DVF4005-25-S | DVF4005-25-S | 2026-10-07 |
| 00840096205107 | 25ga DEX Stiff Morris Honey Badger Forceps | DVF4010-25-S | DVF4010-25-S | 2026-10-07 |
| 00840096205114 | 25ga DEX Stiff Asymmetrical Tano Forceps | DVF4014-25-S | DVF4014-25-S | 2026-10-07 |
| 00840096205121 | 25ga (0.50mm) Dex™ Stiff Serrated Jaw Forceps | DVF4016-25-S | DVF4016-25-S | 2026-10-07 |
| 00840096205138 | 25ga DEX Stiff Maculorhexis Forceps | DVF4019-25-S | DVF4019-25-S | 2026-10-07 |
| 00840096205145 | 25ga DEX Stiff End Grasper Forceps | DVF4022-25-S | DVF4022-25-S | 2026-10-07 |
| 00840096205152 | 25ga DEX Stiff Morris ILM Forceps | DVF4033-25-S | DVF4033-25-S | 2026-10-07 |
| 00840096205169 | 25ga DEX™ Stiff Super Grip Forceps | DVF4034-25-S | DVF4034-25-S | 2026-10-07 |
| 00840096205183 | 25ga DEX Stiff Curved Horizontal Scissors | DVS5006-25-S | DVS5006-25-S | 2026-10-07 |
| 00840096205190 | 25ga DEX Stiff Vertical Scissors | DVS5101-25-S | DVS5101-25-S | 2026-10-07 |
| 00840096215335 | Disposable Bipolar Forceps, 7", 0.5mm Straight Tips | DNK7-05S | DNK7-05S | 2026-10-07 |
| 00840096215342 | Disposable Bipolar Forceps, 7", 1.0mm Straight Tips | DNK7-10S | DNK7-10S | 2026-10-07 |
| 00840096215359 | Disposable Bipolar Forceps, 7", 1.5mm Straight Tips | DNK7-15S | DNK7-15S | 2026-10-07 |
| 00840096215366 | Disposable Bipolar Forceps, 8", 0.5mm Straight Tips | DNK8-05S | DNK8-05S | 2026-10-07 |
| 00840096215373 | Disposable Bipolar Forceps, 8", 1.0mm Straight Tips | DNK8-10S | DNK8-10S | 2026-10-07 |
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| 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 |
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| 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 |
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