25ga Stiff MultiFlex Inverted Laser Probe, Quantel Compatible

Primary DI: 00840096213461
Brand: 25ga Stiff MultiFlex Inverted Laser Probe, Quantel Compatible
Company: KATALYST SURGICAL LLC
Model: V6520-25C-S
Device description: 25ga Stiff MultiFlex Inverted Laser Probe, Quantel Compatible
Published: 2020-12-08
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 table
Code	Name
MPA	Endoilluminator

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
MPA	Endoilluminator	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K121187	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K121187	000	KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES	Katalyst Surgical, LLC	2012-09-17	HQF

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
10840096213468	Primary	GS1	0
00840096213461	Unit of Use	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
10840096213468	10840096213468
00840096213461	00840096213461	840096213461	0840096213461

GMDN Terms#

Term, Definition table
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 table
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 table
Primary DI	Brand	Model	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

Primary DI, Brand, Company table
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

25ga Stiff MultiFlex Inverted Laser Probe, Quantel Compatible

Related Records#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Sterilization Methods#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#