AccessGUDID - DEVICE: Skinister Medical (00810049490645)

GUDID

Device Identifier (DI) Information

Brand Name: Skinister Medical
Version or Model: SA4S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Delta Molding LLC

Primary DI Number: 00810049490645
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080190661 *Terms of Use

Device Description: Silicone pressure sensitive adhesive in hexamethyldisiloxane. 4oz bottle with spray top.

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?
10035	Skin surface device adhesive	A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBJ	Prosthesis, Adhesive, External

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
Storage Environment Temperature: less than 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c087a09d-16aa-424b-84b5-192eecd346b5
Public Version Date: May 22, 2024
Public Version Number: 1
DI Record Publish Date: May 14, 2024