AccessGUDID - DEVICE: STOMAHESIVE (00768455106967)

GUDID

Device Identifier (DI) Information

Brand Name: STOMAHESIVE
Version or Model: 021715
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00768455106967
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: Stomahesive® Skin Barrier - 8" X 8" Wafers

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?
31073	Intestinal stoma shield/support belt, single-use	A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. Also known as a stoma protector it is usually attached by the patient to the base plate/wafer that retains the stomal bag, or might be placed directly over the stomal opening when the bag is removed; it may in addition include an attachable ostomy bag protector. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXE	PROTECTOR, OSTOMY

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: dd2b634c-85dc-450e-b1dd-814b1c6ac778
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10768455106964	10	00768455106967		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00768455178957 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +18004228811
Email: cic@convatec.com

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