AccessGUDID - DEVICE: Alpine BioMed (00570473600874)

GUDID

Device Identifier (DI) Information

Brand Name: Alpine BioMed
Version or Model: 9031A070101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alpine Biomed ApS

Primary DI Number: 00570473600874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 311231554 *Terms of Use

Device Description: Keypoint G4, Intl. 230V ENG

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Electromyograph	A mains electricity (AC-powered) device designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle. The electromyograph (EMG) is typically used in clinical diagnosis of muscular disorders to evaluate muscle weakness and to determine if the weakness is related to the muscles themselves or a problem with the nerves that supply the muscles.

FDA Product Code

[?]

Product Code	Product Code Name
GWF	Stimulator, Electrical, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K944547	000

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: e8b1542f-04c1-4f48-a2a4-4e67dcf31602
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 23, 2016