Model: 665000
DI: 07333350904104
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Mestopore
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
914d19af-09e8-4fc6-a274-fb3013f72e45
Distribution Status:
In Commercial Distribution
DUNS Number:
631770658
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
07333350840136
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
8
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07333350904104
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07333350904104
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 58854
Name: Absorbent stomal dressing
Definition:
An absorbent protective covering/pad intended to be placed over a urinary or enteric stoma to protect it from harmful external influences, absorb and prevent the spread of sweat and stomal fluid/waste/leaks, and to protect the surrounding skin from irritation. It typically has a central hole and is typically attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin, or attached around the connection between an ostomy base plate and an ostomy bag. This is a single-use device.
FDA Product Codes
NAC
Dressing, wound, hydrophilic
Device Sizes
Device Size - Size Text:
10 x 9cm
Device Size - Size Type:
Device Size Text, specify