FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780503972
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
PM-855
Catalog number
PM-855
Device description
Integra® Miltex® DeMayo Two Point Discrimination Device
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWIDiscriminator, two-point

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWIDiscriminator, Two-PointNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780503972PrimaryGS10
H834PM8550SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178050397210381780503972

GMDN Terms#

Term, Definition table
TermDefinition
Two-point aesthesiometerA manual stimulator designed to determine tactile sensibility by testing a patient's two-point touch discrimination. It is typically a two-branched instrument joined at the top by a pivot (compass-like), with two points that are applied to the skin to test touch discrimination. The device is typically used during physical examinations for detecting peripheral neuropathy and/or in diabetes mellitus or leprosy diagnostics. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
H834PM8550Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWI2020-10-01
10381780221722Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWI2017-09-29
M274P8551Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWI2017-09-29
10850828007036AxoTouch™ Two-Point DiscriminatorAXOGEN CORPORATIONGWI2017-05-15