AccessGUDID - DEVICE: The PINPRICK (04262355230631)

GUDID

Device Identifier (DI) Information

Brand Name: The PINPRICK
Version or Model: PP06 8 mN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MRC SYSTEMS GmbH Medizintechnische Systeme

Primary DI Number: 04262355230631
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313871451 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47164	Point aesthesiometer	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXB	Esthesiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c73fbcf3-556c-44b9-98a1-d1f274fa79f0
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022