AccessGUDID - DEVICE: Sigvaris DOFF N’ DONNER SET

GUDID

Device Identifier (DI) Information

Brand Name: Sigvaris DOFF N’ DONNER SET – Single Unit
Version or Model: 15367
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 583D300
Company Name: SIGVARIS INC

Primary DI Number: 00745129278366
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 189738719 *Terms of Use

Device Description: A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).

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:	Yes
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?
31050	Assistive sock/pantyhose dressing device	A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).	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
Device Size Text, specify: No Device Sizes

Device Record Status

Public Device Record Key: 0b7bc91e-344c-49a3-8852-a908c0b78473
Public Version Date: March 19, 2026
Public Version Number: 1
DI Record Publish Date: March 11, 2026