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
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsDNK8-15SDNK8-15S2026-10-08
0081748902541323ga DEX™ Morris ILM ForcepsDVF4033-23DVF4033-232026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsDVF4036-27DVF4036-272026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsDVF4036-23DVF4036-232026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsDVF4036-25DVF4036-252026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsDVF4005-25-SDVF4005-25-S2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsDVF4010-25-SDVF4010-25-S2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsDVF4014-25-SDVF4014-25-S2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsDVF4016-25-SDVF4016-25-S2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsDVF4019-25-SDVF4019-25-S2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsDVF4022-25-SDVF4022-25-S2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsDVF4033-25-SDVF4033-25-S2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsDVF4034-25-SDVF4034-25-S2026-10-07
0084009620518325ga DEX Stiff Curved Horizontal ScissorsDVS5006-25-SDVS5006-25-S2026-10-07
0084009620519025ga DEX Stiff Vertical ScissorsDVS5101-25-SDVS5101-25-S2026-10-07
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsDNK7-05SDNK7-05S2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsDNK7-10SDNK7-10S2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsDNK7-15SDNK7-15S2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsDNK8-05SDNK8-05S2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsDNK8-10SDNK8-10S2026-10-07

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