AccessGUDID - DEVICE: JOBST Elvarex Plus (04059993700806)

GUDID

Device Identifier (DI) Information

Brand Name: JOBST Elvarex Plus
Version or Model: 79541-00020-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 79541-00020-00
Company Name: BSN-Jobst GmbH

Primary DI Number: 04059993700806
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315917492 *Terms of Use

Device Description: ELVAREX PLUS 2/GLOVE/WITH FINGER, WITH THUMB/BEIGE

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):	Yes
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)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123561	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
Device Size Text, specify: Pressure 23-32 mmHg

Device Record Status

Public Device Record Key: 5883a6f0-e210-4497-845a-10ef3c6be33f
Public Version Date: January 19, 2024
Public Version Number: 2
DI Record Publish Date: November 18, 2023