Duns Number:737328851
Device Description: A box of 100 Single-Use Protected Neurological Pins - A disposable precision instrument fo A box of 100 Single-Use Protected Neurological Pins - A disposable precision instrument for testing cutaneous pinprick sensation designed to optimise the patient's perception of sharpness without piercing delicate skin for use in the clinical or non-clinical setting. GMDN Definition: A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device.
Catalog Number
MP-100
Brand Name
Medipin
Version/Model Number
Medipin Pack of 100 Esthesiometers/Sensory Testers
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXB
Product Code Name
Esthesiometer
Public Device Record Key
65be2e12-4e21-4970-abe1-65f0808e10eb
Public Version Date
May 13, 2022
Public Version Number
2
DI Record Publish Date
March 25, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-