AccessGUDID - DEVICE: PLUS (05708590368092)

GUDID

Device Identifier (DI) Information

Brand Name: PLUS
Version or Model: R370385
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R370385000
Company Name: Pressalit A/S

Primary DI Number: 05708590368092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305656662 *Terms of Use

Device Description: PLUS support arm, 850 mm, white. Height adjustable, left hand operated, wall-mounted

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):	Yes
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?
35585	Toilet hand rail	A device of various bar-shaped designs intended to provide a person with a disability a supportive hand-hold when lowering or raising their body to or from the toilet. It may be designed to be wall-mounted or affixed to the toilet.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILS	Adaptor, Hygiene

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: 4509a874-4d30-4982-a5b8-afec68444bda
Public Version Date: June 16, 2020
Public Version Number: 1
DI Record Publish Date: June 08, 2020