AccessGUDID - DEVICE: Isolation Device Mixed pack (00860013000394)

GUDID

Device Identifier (DI) Information

Brand Name: Isolation Device Mixed pack
Version or Model: 00860013000394
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00860013000394
Company Name: Fistula Solution Corporation

Primary DI Number: 00860013000394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007596766 *Terms of Use

Device Description: Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip®

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):	No
Kit:	Yes
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?
47658	Ostomy convexity insert	A device designed to help improve contact between the flange of a two-piece or multiple-piece ostomy appliance and the peristomal skin of a flush stoma or more typically a recessed stoma (a stoma with an adjacent depression, scar, crease, or other condition) for which additional barrier-to-skin contact is desirable. The device is placed between the ostomy appliance flange and the stomal skin typically to fill gaps between the two by providing convexity (an outward bulge), reducing the likelihood of leakage. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZS	Appliance, Colostomy, Disposable

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: 3d22716c-b979-42d7-b95c-8f3e3682a2f5
Public Version Date: December 08, 2023
Public Version Number: 1
DI Record Publish Date: November 30, 2023