FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834015996000
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
015-99600
Catalog number
015-99600
Device description
Chiropractic Mallet
Published
2018-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10381780168959PrimaryGS10
H834015996000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178016895910381780168959

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10381780168997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLXM2018-09-12