Model: 5091010
Catalog: 5091010
DI: 00813954028385
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Microfibrillar Collagen
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
105ab5be-d082-41e2-bc7f-f2e20b9267da
Distribution Status:
In Commercial Distribution
DUNS Number:
176262442
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
Box
Item #1 - Device ID:
10813954028382
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00813954028385
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00813954028385
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00614950007820
Item #3 - Device ID Type:
Previous
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 47184
Name: General oral wound dressing, animal-derived
Definition:
A collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.
FDA Product Codes
KGN
Wound Dressing With Animal-Derived Material(S)
Device Sizes
Device Size - Size Text:
0.1 gram
Device Size - Size Type:
Device Size Text, specify
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
15
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
30
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling Low - @attributes - Value:
59
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling High - @attributes - Value:
86
Item #2 - Storage Handling Type:
Storage Environment Temperature