AccessGUDID - DEVICE: SUR-FIT NATURA (00768455103614)

GUDID

Device Identifier (DI) Information

Brand Name: SUR-FIT NATURA
Version or Model: 401545
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00768455103614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 2 1/4"

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?
31069	Multiple-piece urostomy bag, open-ended	A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXH	BAG, URINARY, ILEOSTOMY

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: 3c406c87-e828-4008-9767-b757e59f40b2
Public Version Date: October 27, 2022
Public Version Number: 3
DI Record Publish Date: December 07, 2018