Model: 5072
Catalog: 5072
DI: 20192253046196
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Kerlix Sponges
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
879bbb3a-c75a-49e6-9c67-92122cb43055
Distribution Status:
In Commercial Distribution
DUNS Number:
961027315
Device Count:
2
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:
50192253046197
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
24
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
30192253046193
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Tray
Item #2 - Device ID:
30192253046193
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
25
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
20192253046196
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
20192253046196
Item #3 - Device ID Type:
Primary
Item #3 - Device ID Issuing Agency:
GS1
Item #4 - Device ID:
10192253046199
Item #4 - Device ID Type:
Unit of Use
Item #4 - Device ID Issuing Agency:
GS1
GMDN
Code: 48131
Name: Non-woven gauze pad
Definition:
A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.
FDA Product Codes
NAB
Gauze / sponge,nonresorbable for external use
Device Sizes
Item #1 - Size - @attributes - Unit:
Inch
Item #1 - Size - @attributes - Value:
4
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Inch
Item #2 - Size - @attributes - Value:
4
Item #2 - Size Type:
Width