FDA.reportPublic FDA data

Khaimi Concentrator, 0.35

Primary DI
00840096207576
Brand
Khaimi Concentrator, 0.35
Company
KATALYST SURGICAL LLC
Model
9000-35
Device description
Khaimi Concentrator, 0.35
Published
2020-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096207576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096207576008400962075768400962075760840096207576

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic working-channel cannula, reusableA rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
1081748902630125ga DEX™ Slim Morris ILM ForcepsDVFO4033-25DVFO4033-252020-09-21
1081748902631827ga DEX™ Stiff Slim Morris ILM ForcepsDVFO4033-27DVFO4033-272020-09-21
1081748902714823ga DEX™ Hassan ForcepsDVF4035-23DVF4035-232020-11-01
1081748902716227ga DEX Stiff Hassan ForcepsDVF4035-27DVF4035-272020-11-01
1081748902731523ga Slim DEX™ Hassan ForcepsDVFO4035-23DVFO4035-232020-09-21
1081748902732225ga Slim DEX™ Hassan ForcepsDVFO4035-25DVFO4035-252020-09-21
1081748902733927ga Stiff Slim DEX™ Hassan ForcepsDVFO4035-27DVFO4035-272020-09-21
1081748902735327ga Slim DEX™ Vertical ScissorsDVSO5101-272020-11-01
1081748902739123ga MultiFlex Laser Probe, Iridex CompatibleXLEND23MULTIFLEXAXLEND23MULTIFLEXA2018-11-26
1084009621104423ga Slim DEX™ Super Grip II ForcepsDVFO4036-23DVFO4036-232020-09-21
1084009621110525ga Slim DEX™ Super Grip II ForcepsDVFO4036-25DVFO4036-252020-09-21
1084009621111227ga Stiff Slim DEX™ Super Grip II ForcepsDVFO4036-27DVFO4036-272020-09-21
1084009621117425ga Stiff DEX™ Yoneda Super Grip ForcepsDVF4036-25-SDVF4036-25-S2020-11-01
1084009621289823ga DEX™ EZPeel ForcepsDVF4037-23DVF4037-232020-07-06
1084009621290425ga DEX™ EZPeel ForcepsDVF4037-25DVF4037-252020-07-06
1084009621291127ga DEX™ EZPeel ForcepsDVF4037-27DVF4037-272020-07-06
1084009621292825ga Stiff DEX™ EZPeel ForcepsDVF4037-25-SDVF4037-25-S2020-07-06
1084009621293523ga Slim DEX™ EZPeel ForcepsDVFO4037-23DVFO4037-232020-07-06
1084009621294225ga Slim DEX™ EZPeel ForcepsDVFO4037-25DVFO4037-252020-07-06
1084009621295925ga Slim Stiff DEX™ EZPeel ForcepsDVFO4037-25-SDVFO4037-25-S2020-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433185MillenniumAvalign Technologies, Inc.HNQ2026-10-01
00190776432768MillenniumAvalign Technologies, Inc.HNQ2026-09-29
03700483630219MORIAMORIA SAHNQ2026-09-25
00190776423940MillenniumAvalign Technologies, Inc.HNQ2026-08-27
00190776419714MillenniumAvalign Technologies, Inc.HNQ2026-08-25
G22314029320Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-08-03
B382S340861340Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
B382S344922000Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
00198506092145ELMED INCORPORATEDELMED INCORPORATEDHNQ2026-07-27
G22312240810Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223140340L0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223145830T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
00190776400378MillenniumAvalign Technologies, Inc.HNQ2026-07-17
00190776395728MillenniumAvalign Technologies, Inc.HNQ2026-07-14
13700773729644IRIS RETRACTOR 5 HOOKSFCI S A S FCI 20 22HNQ2026-07-09
00757770451531Bausch + LombBausch & Lomb IncorporatedHNQ2026-06-22
04251047903076Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047903359Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047904745Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047925849Vera Fixation HookA1 Medical GmbHHNQ2026-05-29
00190776421151MillenniumAvalign Technologies, Inc.HNQ2026-05-04
00190776420833MillenniumAvalign Technologies, Inc.HNQ2026-04-30
00757770522750Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00757770636082Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00190776420086MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776420093MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776419912MillenniumAvalign Technologies, Inc.HNQ2026-04-15
00190776414214MillenniumAvalign Technologies, Inc.HNQ2025-10-22
00810163790447Diamatrix Ltd.DiamatrixHNQ2025-10-21