FDA.reportPublic FDA data

Khaimi Concentrator, 0.25 mL

Primary DI
00840096203660
Brand
Khaimi Concentrator, 0.25 mL
Company
KATALYST SURGICAL LLC
Model
9001-25
Published
2019-07-02
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
HBQInstrument, Clip Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBQInstrument, Clip RemovalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096203660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096203660008400962036608400962036600840096203660

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
10817489027483Laser Probe OS4, MultiFlex, 23gaVK4003032019-03-19
10817489027490Laser Probe OS4, MultiFlex, 25gaVK4003052019-03-19
10817489027506Laser Probe OS4, MultiFlex Inverted, 23gaVK4003132019-03-19
10817489027513Laser Probe OS4, MultiFlex Inverted, 25gaVK4003152019-03-19
10817489027520Laser Probe OS4, MultiFlex Extendable, 23gaVK4003232019-03-19
10817489027544Laser Probe OS4, MultiFlex Inverted Extendable, 23gaVK4003332019-03-19
10817489027551Laser Probe OS4, MultiFlex Inverted Extendable, 25gaVK4003352019-03-19
1084009621123520ga Straight Laser Probe6202002020-03-04
1084009621124223ga Straight Laser Probe6202012020-03-04
1084009621125925ga Straight Laser Probe6202022020-03-04
1084009621126627ga Straight Laser Probe6202032020-03-04
1084009621127323ga Flexible Curved Laser Probe6202102020-03-04
1084009621128025ga Flexible Curved Laser Probe6202112020-03-04
1084009621129727ga Flexible Curved Laser Probe6202122020-03-04
1084009621130320ga Illuminated Straight Laser Probe6202202020-03-04
1084009621131023ga Illuminated Straight Laser Probe6202212020-03-04
1084009621132725ga Illuminated Straight Laser Probe6202222020-03-04
1084009621133427ga Illuminated Straight Laser Probe6202232020-03-04
1084009621134123ga Illuminated Flexible Curved Laser Probe6202292020-03-04
1084009621135825ga Illuminated Flexible Curved Laser Probe6202302020-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653170036AESCULAPAesculap AGHBQ2020-08-10
00840096207583Khaimi Concentrator, Smooth, 0.45KATALYST SURGICAL LLCHBQ2020-06-08
04038653170005AESCULAPAesculap AGHBQ2020-04-22
04038653170012AESCULAPAesculap AGHBQ2020-04-22
04038653170029AESCULAPAesculap AGHBQ2020-04-22
00840096203684Khaimi Concentrator, 0.33 mLKATALYST SURGICAL LLCHBQ2019-07-02
00840096203691Khaimi Concentrator, 0.35 mLKATALYST SURGICAL LLCHBQ2019-07-02
00857987006187Vitalitec Clip RemoversVITALITEC INTERNATIONAL, INC.HBQ2018-12-13
00857987006194Vitalitec Clip RemoversVITALITEC INTERNATIONAL, INC.HBQ2018-12-13
24026704508758PILLINGTELEFLEX INCORPORATEDHBQ2018-09-15
10884521057616Lapro-ClipCovidien LPHBQ2018-08-10
00810607000453Clip Remover ACRA-CUT INCHBQ2017-05-01