FDA.reportPublic FDA data

The PINPRICK

Primary DI
04262355230587
Brand
The PINPRICK
Company
MRC SYSTEMS GmbH Medizintechnische Systeme
Model
PP05 256 mN
Device description
MRC's PinPrick stimulators are used for quantitative sensory testing (QST) of pain and perception thresholds. They allow a reproducible measurement and documentation of nociceptor activation of the skin. Thus, they enable a better diagnostic of symptoms of neuropathologic pain and the investigation of mechanisms that are connected with chronic pain.
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
04262355230587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262355230587042623552305874262355230587

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
Premarket exempt
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
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
04262355232109OptiHair2VF2022-12-07

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
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
00384705405033NeurotipsOWEN MUMFORD LIMITEDGXB2019-10-03