AccessGUDID - DEVICE: SCT 2000 (05708590372167)

GUDID

Device Identifier (DI) Information

Brand Name: SCT 2000
Version or Model: R8425218
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R8425218000
Company Name: Pressalit A/S

Primary DI Number: 05708590372167
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305656662 *Terms of Use

Device Description: SCT 2000 shower change table, mesh cover, lying surface 21.7'' x 65'', with safety rail and water collection tray, foldable, white. Fixed height, 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?
43600	Bathing/changing table, stationary	A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off), either mounted on a fixed frame with legs or wall-mounted (may be height-adjustable), designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff) or shower. The device is used primarily for a patient with a disability incapable of supporting themself in an upright position. It is designed to be stationary and is used in one location.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INT	Plinth

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: 79313a43-70cd-4c99-8eae-4eedd70eab66
Public Version Date: November 23, 2021
Public Version Number: 1
DI Record Publish Date: November 15, 2021