AccessGUDID - DEVICE: Compression Stocking (G420106)

GUDID

Device Identifier (DI) Information

Brand Name: Compression Stocking
Version or Model: 106
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 106
Company Name: Gottfried Medical, Inc.

Primary DI Number: G420106
Issuing Agency: HIBCC
Commercial Distribution End Date: June 04, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 038706180 *Terms of Use

Device Description: Gauntlet

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):	Yes
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?
16500	Compression/pressure glove	A device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
FQL	Stocking, Medical Support (For General Medical Purposes)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K823737	000

Device Exempt from Premarket Submission: No 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: e333fa93-0513-4087-8202-a47259d0c405
Public Version Date: June 05, 2026
Public Version Number: 3
DI Record Publish Date: August 15, 2023