FDA.reportPublic FDA data

Neurotips

Primary DI
00384705405019
Brand
Neurotips
Company
OWEN MUMFORD LIMITED
Model
NT 0100
Device description
Sterile single use neuropathy screening pins
Published
2019-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXBEsthesiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXBEsthesiometerNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384705405026PackageGS15In Commercial Distribution
00384705405033PackageGS120In Commercial Distribution
00384705405019PrimaryGS10
00384705405002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384705405026003847054050263847054050260384705405026
00384705405033003847054050333847054050330384705405033
00384705405019003847054050193847054050190384705405019
00384705405002003847054050023847054050020384705405002

GMDN Terms#

Term, Definition table
TermDefinition
Pressure algometer/aesthesiometer, mechanicalA manual, non-powered instrument designed to measure: 1) a patient's sensitivity to pain (pain threshold) by applying a painful, calibrated mechanical force to the skin; and 2) tactile sensibility by application of a thin filament(s) to the skin. It is typically a holder/pen which includes a strain gauge, a pressure algesimeter tip(s), and a thin filament(s) with a pre-set flexibility intended to apply a known pressure (point aesthesiometer). The device is typically used to evaluate the effects of pain after the use of anaesthesia/analgesics and/or during diagnosis or treatment of nerve injuries and neuropathies. This is a reusable device when the consumable products have been replenished.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
770-977-2226info.us@owenmumford.com

Regulatory Flags#

DUNS number
217266915
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384703800014Autopen AN3800AN38002016-09-19
00384703810013Autopen AN3810AN38102016-09-19
00384700752019Unistik 2 Safety Lancets - Super 18GAT 07522020-04-16
00384701402012Unistik TouchAT 14022023-03-30
00384701402036Unistik TouchAT 14022023-03-30
00384700702014UnistikAT 07022020-04-16
00384700704018UnistikAT 07042020-04-16
00384700712013Unistik AT 07122020-04-16
00384700714017Unistik AT 07142020-04-16
00384700747015Unistik AT 07472020-04-16
00384701422010Unistik TouchAT 14222021-03-26
00384701442018Unistik Touch AT 14422021-03-26
00384701015014Unistik AT 10152023-02-07
00384701027017Unistik 3AT 10272023-02-07
00384701614019Unistik ProAT 16142023-02-07
00384701634017Unistik ProAT 16342023-02-07
00384701644016Unistik ProAT 16442023-02-07
00384701015038Unistik AT 10152023-02-07
00384701027024Unistik 3AT 10272023-02-07
00384701614033Unistik ProAT 16142023-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060418832285Bailey Retractable Monofilament 10gBAILEY INSTRUMENTS LTDGXB2024-01-23
08908022363016NEURO TOUCHYOSTRA LABS PRIVATE LIMITEDGXB2024-01-10
00609271039803DARCO® Monofilament TesterDARCO INTERNATIONAL, INC.GXB2023-02-08
00609271000094DARCO® Foot FilamentDARCO INTERNATIONAL, INC.GXB2023-02-08
10609271039800DARCO® Monofilament TesterDARCO INTERNATIONAL, INC.GXB2023-02-08
04262355230501The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230532The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230549The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230556The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230563The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230570The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230587The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230594The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230600The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230631The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230648The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230655The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230662The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230679The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230686The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355230693The PINPRICKMRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
04262355232109OptiHair2MRC SYSTEMS GmbH Medizintechnische SystemeGXB2022-12-07
05060631140006Medipin MEDIPIN LIMITEDGXB2021-03-25
05060631140013MedipinMEDIPIN LIMITEDGXB2021-03-25
00384700100018NeuropenOWEN MUMFORD LIMITEDGXB2019-10-03
00384700104016Neuropen Monofilaments 10gOWEN MUMFORD LIMITEDGXB2019-10-03
00384700100032NeuropenOWEN MUMFORD LIMITEDGXB2019-10-03
00384700104030Neuropen Monofilaments 10gOWEN MUMFORD LIMITEDGXB2019-10-03
00384705405033NeurotipsOWEN MUMFORD LIMITEDGXB2019-10-03