FDA.reportPublic FDA data

OptiHair2

Primary DI
04262355232109
Brand
OptiHair2
Company
MRC SYSTEMS GmbH Medizintechnische Systeme
Model
VF
Device description
"The ""OptiHair2"" - von Frey filaments are used to investigate the tactile detection threshold in quantitative sensory testing (QST). "
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04262355232109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262355232109042623552321094262355232109

GMDN Terms#

Term, Definition table
TermDefinition
Point aesthesiometerA manual stimulator designed to determine tactile sensibility by patient response to the manual application of a thin filament(s) to the skin. It typically consists of a filament(s) with a pre-set flexibility and is intended to apply a known pressure upon application; the filament is attached to an appropriate handle/base that may also be intended to be loaded into a dedicated pen/holder. The device is typically used during diagnosis or treatment of nerve injuries and neuropathies associated with e.g., diabetes mellitus or leprosy. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4962211380300info@mrc-systems.de

Regulatory Flags#

DUNS number
313871451
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262355230501The PINPRICKPP05 Set2022-12-07
04262355230532The PINPRICKPP05 8 mN2022-12-07
04262355230549The PINPRICKPP05 16mN2022-12-07
04262355230556The PINPRICKPP05 32 mN2022-12-07
04262355230563The PINPRICKPP05 64mN2022-12-07
04262355230570The PINPRICKPP05 128 mN2022-12-07
04262355230587The PINPRICKPP05 256 mN2022-12-07
04262355230594The PINPRICKPP05 512 mN2022-12-07
04262355230600The PINPRICKPP06 Set2022-12-07
04262355230631The PINPRICKPP06 8 mN2022-12-07
04262355230648The PINPRICKPP06 16 mN2022-12-07
04262355230655The PINPRICKPP06 32 mN2022-12-07
04262355230662The PINPRICKPP06 64 mN2022-12-07
04262355230679The PINPRICKPP06 128 mN2022-12-07
04262355230686The PINPRICKPP06 256 mN2022-12-07
04262355230693The PINPRICKPP06 512 mN2022-12-07

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
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
00384705405033NeurotipsOWEN MUMFORD LIMITEDGXB2019-10-03