AccessGUDID - DEVICE: Alpine Biomed (05704736000475)

GUDID

Device Identifier (DI) Information

Brand Name: Alpine Biomed
Version or Model: 9013L0352
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alpine Biomed ApS

Primary DI Number: 05704736000475
Issuing Agency: GS1
Commercial Distribution End Date: April 28, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 311231554 *Terms of Use

Device Description: Hand-held Bipolar Stimulator, Two 3 mm felt tips, diameter pads 10 mm apart, 2 m cable, 5-pin DIN

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):	Yes
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?
35729	Diagnostic peripheral nerve electrical stimulation system	An assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 16b22021-7a10-4aa4-bc84-10d13ad1d9ff
Public Version Date: April 29, 2020
Public Version Number: 3
DI Record Publish Date: October 13, 2016