FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780168997
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
015-99613
Catalog number
015-99613
Device description
Integrator™ Chiropractic Adjustment Instrument - Tips Only, Gray - 100 Pack
Published
2018-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXMMANIPULATOR, PLUNGER-LIKE JOINT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXMManipulator, Plunger-Like JointUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950646000INTEGRATORMoyco Union Broach, Div., Moyco Technologies, Inc.1996-04-30LXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780168997PrimaryGS10
H834015996131SecondaryHIBCC0
00381780168990Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178016899710381780168997
00381780168990003817801689903817801689900381780168990

GMDN Terms#

Term, Definition table
TermDefinition
Joint/spinal manipulator, mechanicalA hand-held, non-electric, mechanically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. The instrument uses a manually-operated, mechanical, plunger-like mechanism (e.g., spring-loaded) to deliver thrust to the patient's body via its rounded distal end (e.g., rubber-tipped stylus); it typically has two or more force settings. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011416494ProAdjuster KidzNeuromechanical Innovations, L.L.C.LXM2025-05-01
00860011416487Prosoft SRTNeuromechanical Innovations, L.L.C.LXM2024-02-08
00086001141645Prosoft GTNeuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416401Impulse Adjusting InstrumentNeuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416418Impulse iQ Adjusting InstrumentNeuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416463Prosports 360Neuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416470ProAdjuster SRTNeuromechanical Innovations, L.L.C.LXM2024-01-13
00855341008006PulStarSense Technology, Inc.LXM2023-07-03
10855341008003PulStarSense Technology, Inc.LXM2023-07-03
B733KDY10KDY1Sigma Instruments, Inc.LXM2022-12-28
B733KDY20KDY2Sigma Instruments, Inc.LXM2022-12-28
B733KDYST0KDY-STSigma Instruments, Inc.LXM2022-12-28
B854M20Khan Kinetic Treatment Device (KKT-M2)Optima Health Solutions International CorporationLXM2022-03-24
G041CT0010Original CATJTECH MedicalLXM2021-05-14
G041CT0060CAT EXJTECH MedicalLXM2021-05-14
G041CT0120CAT Pro SelectJTECH MedicalLXM2021-05-14
00850021303013Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303020Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303044Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303051Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303082Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303099Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303105Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303112Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303129Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
00850021303136Activator MethodsActivator Methods International, Ltd.LXM2020-10-16
10381780168959Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12
10381780168966Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12
10381780168980Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12
H834015996000Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12