AccessGUDID - DEVICE: Stand Assist Sling with Clips Large (05056387416670)

GUDID

Device Identifier (DI) Information

Brand Name: Stand Assist Sling with Clips Large
Version or Model: M921525-L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SILVALEA LIMITED

Primary DI Number: 05056387416670
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 423632996 *Terms of Use

Device Description: No description.

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):	No
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?
45382	Stand-up mobile patient lifting system sling/harness	A lifting device used together with a stand-up mobile lift system to provide a support for an incapacitated patient or a person with a disability that is being lifted from a sitting to a standing position for transfer, (re)positioning and use of a toilet. It is also used to support the patient/person in a standing position to assist in dressing them. It is designed as a sling/harness construction made of straps which is strapped around the person's chest and which will cradle and hold their body during the lifting process. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INE	Sling, Overhead Suspension, Wheelchair

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: b0b6f579-f03a-4330-b39f-f2dac8b646d3
Public Version Date: March 07, 2024
Public Version Number: 1
DI Record Publish Date: February 28, 2024