AccessGUDID - DEVICE: PLUS (05708590309415)

GUDID

Device Identifier (DI) Information

Brand Name: PLUS
Version or Model: R4580112
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R4580112
Company Name: Pressalit A/S

Primary DI Number: 05708590309415
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305656662 *Terms of Use

Device Description: PLUS wash basin bracket, track-mounted, with anthracite cover plate. Manually height adjustable with tilt lock, and manually sideways adjustable

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?
63052	Height-adjustable washbasin bracket, manual	A wall fixture with a manual height-adjustable mechanism designed to accept a washbasin enabling disabled patients to adjust the washbasin height to meet their needs. It includes a manually-operated mechanism (e.g., lever) which may include a gas cylinder for pneumatic assistance (power-assisted, not pneumatic power) and is designed to accommodate specific plumbing/weight requirements.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILW	Adaptor, Grooming

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: 0698cbaf-f994-45ba-a47c-31be1ecb8ef4
Public Version Date: June 16, 2020
Public Version Number: 1
DI Record Publish Date: June 08, 2020