AccessGUDID - DEVICE: SELECT TL4 (05708590372952)

GUDID

Device Identifier (DI) Information

Brand Name: SELECT TL4
Version or Model: R9044
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R9044000
Company Name: Pressalit A/S

Primary DI Number: 05708590372952
Issuing Agency: GS1
Commercial Distribution End Date: February 16, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 305656662 *Terms of Use

Device Description: SELECT TL4 toilet bracket, for wall outlet, prepared for shower toilet seat, 120V, white single molded cover. Manually height adjustable with crank handle

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?
63053	Height-adjustable toilet bracket, manual	A wall fixture with a manual height-adjustable mechanism designed to accept a toilet enabling disabled patients to adjust the toilet height to meet their needs. It includes a manually-operated mechanism (e.g., lever) which might 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
IKX	Aid, Transfer

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: 0103ba19-d879-4860-b929-90a545fe2d34
Public Version Date: February 16, 2021
Public Version Number: 2
DI Record Publish Date: August 06, 2020