FDA.reportPublic FDA data

Rod Holder Plier

Primary DI
10840199532527
Brand
Rod Holder Plier
Company
KOROS U.S.A., INC.
Model
7780-34
Catalog number
7780-34
Device description
"Rod Holder Plier for 4-8mm Rod, 9-3/4"" 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199532520Direct MarkingGS10
10840199532527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199532520008401995325208401995325200840199532520
1084019953252710840199532527

GMDN Terms#

Term, Definition table
TermDefinition
Wire holding/twisting pliersA heavy-duty manual surgical instrument with specially-designed sturdy handles and blade jaws used to grip, tighten, and/or twist wires during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically short and broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10840199516008Fiberoptic Light Port7332-627332-622024-12-31
10840199516015Fiberoptic Light Port7332-647332-642024-12-31
10840199531056Impactor7585-027585-022022-03-01
10840199531186Impactor7585-447585-442022-03-01
10840199528834Comfort Plus Chisel7540-067540-062025-01-31
00840199528837Comfort Plus Chisel7540-067540-062025-01-31
10840199500007Dilator Tube Set, Single Use, Sterile 7332-99D7332-99D2022-01-31
10840199507723Separator7230-107230-102024-12-31
10840199507730Separator7230-157230-152024-12-31
10840199507747Elevator7230-187230-182024-12-31
10840199507754Elevator7230-207230-202024-12-31
10840199507761Elevator7230-257230-252024-12-31
10840199507778Elevator7230-307230-302024-12-31
10840199507785Elevator7230-357230-352024-12-31
10840199507792Elevator7230-407230-402024-12-31
10840199507808Elevator7230-427230-422024-12-31
10840199507815Elevator7230-437230-432024-12-31
10840199507877Elevator7230-607230-602024-12-31
10840199507907Hook7232-057232-052024-12-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
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