AccessGUDID - DEVICE: Konmed (06970935830260)

GUDID

Device Identifier (DI) Information

Brand Name: Konmed
Version or Model: KM-W-35
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Konmed Technology Co., Ltd.

Primary DI Number: 06970935830260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544436531 *Terms of Use

Device Description: It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustableit is designed with below feature: - Dual function, including separation fingers and training fingers - Aluminum alloy make good supporting - Extractable aluminum alloy is, for easy cleaning and adjustment - Velcro is vertical arrangementfor easy wearing

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?
61652	Tubular support bandage, non-latex, reusable	A tubular, elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQX	Device, Finger-Sucking

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: 2c600f43-11f6-4688-bfca-5893417ca4ca
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: January 24, 2018