AccessGUDID - DEVICE: GluGone Adhesive Remover, 2 oz. (00854137001719)

GUDID

Device Identifier (DI) Information

Brand Name: GluGone Adhesive Remover, 2 oz.
Version or Model: GG80212
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GG80212
Company Name: Chemence Medical, Inc.

Primary DI Number: 00854137001719
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079163089 *Terms of Use

Device Description: Glugone 2 oz

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):	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?
60494	Patient medical adhesive remover	A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOX	Solvent, Adhesive Tape

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: Yes
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: 51219bce-8be6-42b7-b407-f1f1877f558a
Public Version Date: August 15, 2024
Public Version Number: 2
DI Record Publish Date: June 27, 2022