FDA.reportPublic FDA data

GENERIC Surgical Instruments

Primary DI
00841732144309
Brand
GENERIC Surgical Instruments
Company
CTL Medical Corporation
Model
119.7087
Device description
Wrench Extended Fork, 10mm
Published
2023-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXCWrench

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732144309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732144309008417321443098417321443090841732144309

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2145455820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841732168268VALEO II LL Interbody Fusion System91.020.22082025-06-30
00841732168275VALEO II LL Interbody Fusion System91.020.22102025-06-30
00841732168282VALEO II LL Interbody Fusion System91.020.22142025-06-30
00841732167377VALEO II PL OL Interbody Fusion System11.113.46132025-01-23
00841732167384VALEO II PL OL Interbody Fusion System11.113.48152025-01-23
00841732167339GENERIC Surgical Instruments31-5500-0022024-12-11
00841732141186VALEO II PL OL Interbody Fusion System91.000.90092024-11-01
00841732158658Valeo II LL110-3232024-11-01
00841732158665Valeo II LL110-3242024-11-01
00841732158672Valeo II LL110-3292024-11-01
00841732165236VALEO II LL Interbody Fusion System91.020.12002024-11-01
00841732166219VALEO II PL OL Interbody Fusion System11.113.47152024-11-01
00841732166820VALEO II LL Interbody Fusion System91.020.10012024-11-01
00841732167322VALEO II LL Interbody Fusion System91.020.10992024-11-01
00841732144361VALEO II C Interbody Fusion System12.600.16102023-09-27
00841732144378VALEO II C Interbody Fusion System12.600.16052023-09-27
00841732145610VALEO II C Interbody Fusion System12.600.10052023-09-27
00841732145627VALEO II C Interbody Fusion System12.600.16062023-09-27
00841732145634VALEO II C Interbody Fusion System12.600.16082023-09-27
00841732145641VALEO II C Interbody Fusion System12.600.20052023-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B756007053001000Torque WrenchShukla MedicalHXC2026-06-01
10886982362964NASynthes GmbHHXC2026-05-04
08059386742273Orthopaedic Surgical InstrumentsCITIEFFE SRLHXC2025-11-05
1085007050056915mm CurvaFix Hex Wrench CURVAFIX, INC.HXC2025-10-22
10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
18059015376494ORTHOFIXORTHOFIX SRLHXC2025-03-31
18059015376029TRUELOK SYSTEMORTHOFIX SRLHXC2025-01-10
10840199540805Modified Kaufman Type Kidney ClampKOROS U.S.A., INC.HXC2024-01-31
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
10845854023976ULTRAPOWERConmed CorporationHXC2022-06-02
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B07301K0380850Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0381200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
10886982195722NASynthes GmbHHXC2019-02-21
08809265159063Surgical InstrumentJeil Medical CorporationHXC2018-11-28