Duns Number:737328851
Device Description: A carton of 12 Single-Use Protected Neurological Pins intended to allow patients with diab A carton of 12 Single-Use Protected Neurological Pins intended to allow patients with diabetes to test themselves safely at home monthly for early signs of diabetic neuropathy according to American Diabetes Association guidelines - 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-12
Brand Name
Medipin
Version/Model Number
The Diabetic Toes Test by Medipin
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
f6bc8a07-b69f-4b05-b16c-a2660f5e863f
Public Version Date
April 02, 2021
Public Version Number
1
DI Record Publish Date
March 25, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-