FDA.report

Modified Kaufman Type Kidney Clamp

Primary DI
00840199540808
Brand
Modified Kaufman Type Kidney Clamp
Company
KOROS U.S.A., INC.
Model
9874-10
Catalog number
9874-10
Device description
Modified Kaufman Type Kidney Clamp 14cm 5-1/2" Jaw Length, 39cm 15-1/2" Total Length
Published
2024-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXCWrench

Product Code Classifications

CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840199540808Direct MarkingGS10
10840199540805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199540808008401995408088401995408080840199540808
1084019954080510840199540805

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840199528837Comfort Plus Chisel7540-067540-062025-01-31
00840199507726Separator7230-107230-102024-12-31
00840199507733Separator7230-157230-152024-12-31
00840199507740Elevator7230-187230-182024-12-31
00840199507757Elevator7230-207230-202024-12-31
00840199507764Elevator7230-257230-252024-12-31
00840199507771Elevator7230-307230-302024-12-31
00840199507788Elevator7230-357230-352024-12-31
00840199507795Elevator7230-407230-402024-12-31
00840199507801Elevator7230-427230-422024-12-31
00840199507818Elevator7230-437230-432024-12-31
00840199507870Elevator7230-607230-602024-12-31
00840199507900Hook7232-057232-052024-12-31
00840199507917Hook7232-107232-102024-12-31
00840199507924Hook7232-157232-152024-12-31
00840199507962Elevator7232-287232-282024-12-31
00840199507979Vein Retractor7232-307232-302024-12-31
00840199507986Vein Retractor7232-357232-352024-12-31
00840199507993Vein Retractor7232-407232-402024-12-31
00840199511426Chisel7315-217315-212024-12-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150072064Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-05-23
00840493416540LUX Expandable Interbody SystemXENIX MEDICAL LLCHXC2026-03-13
00888867500785Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500808Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500815Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500853Arthrex®ARTHREX, INC.HXC2026-03-13
00199150065974Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-02-28
00190376731988IdentiTi IIALPHATEC SPINE, INC.HXC2026-02-18
03662663131636Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131643Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131650Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
00840180543948General InstrumentsALPHATEC SPINE, INC.HXC2025-12-31
03662663198202Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXC2025-12-17
03662663216760Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663216777Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663191906Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-12-16
03662663136549Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136556Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136563Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663137249Polaris 4.75 Deformity SystemHighridge Medical, LLCHXC2025-11-14
03662663161466The Tether Vertebral Body Tethering SystemHighridge Medical, LLCHXC2025-11-14
03662663192385InCompass Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663194129PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXC2025-11-14
00199150051199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2025-11-13
00840314269768gSourceGSOURCE LLCHXC2025-08-29
00889797111195Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111201Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111218Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111225Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797112642N/AWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26