FDA.reportPublic FDA data

Khaimi Concentrator, Smooth, 0.45

Primary DI
00840096207583
Brand
Khaimi Concentrator, Smooth, 0.45
Company
KATALYST SURGICAL LLC
Model
9001-45
Device description
Khaimi Concentrator, Smooth, 0.45
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
HBQInstrument, Clip Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBQInstrument, Clip RemovalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096207583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096207583008400962075838400962075830840096207583

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

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10817489025304Cyclophotocoagulation Probe, Iridex ConnectorXLCYCLOA2018-12-11
10817489025151Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700A2017-07-21
10817489025168Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700C2017-07-21
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1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-20CR2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-20ER2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCV6300-20JR2020-11-27
1081748902361423ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-23AR2020-11-25
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-23BR2020-11-27
1081748902363823ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-23CR2020-11-27
1081748902364523ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-23ER2020-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653170036AESCULAPAesculap AGHBQ2020-08-10
04038653170005AESCULAPAesculap AGHBQ2020-04-22
04038653170012AESCULAPAesculap AGHBQ2020-04-22
04038653170029AESCULAPAesculap AGHBQ2020-04-22
00840096203660Khaimi Concentrator, 0.25 mLKATALYST SURGICAL LLCHBQ2019-07-02
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