FDA.reportPublic FDA data

Neurotips

Primary DI
00384705405033
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
Rx
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
217266915
Device count
100
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00384705405019NeurotipsOWEN MUMFORD LIMITEDGXB2019-10-03
00384700100032NeuropenOWEN MUMFORD LIMITEDGXB2019-10-03
00384700104030Neuropen Monofilaments 10gOWEN MUMFORD LIMITEDGXB2019-10-03