AccessGUDID - DEVICE: SUR-FIT NATURA (00768455107124)

GUDID

Device Identifier (DI) Information

Brand Name: SUR-FIT NATURA
Version or Model: 404008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00768455107124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: SUR-FIT Natura® Disposable Convex Inserts, 1" Inner Diameter, Flange Size 1 1/2"

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:	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?
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: 68df8608-08b9-4aac-ab4b-b210b1d40e44
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022