Model: 66027688
Catalog: 66027688
DI: 05000223502331
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
ACTICOAT FLEX 16"x16" CTN 6 US
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
053fcd0a-9e4e-4a9d-9b8a-51d7125b67c1
Distribution Status:
In Commercial Distribution
DUNS Number:
216344051
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:
CAR
Item #1 - Device ID:
05000223503260
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
6
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05000223502331
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05000223502331
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
CAS
Item #3 - Device ID:
05000223503277
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
2
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
05000223503260
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 47042
Name: Wound-nonadherent dressing, absorbent, antimicrobial
Definition:
A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.
FDA Product Codes
FRO
Dressing, wound, drug
Premarket Submissions
Submission Number:
K083113
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Inch
Item #1 - Size - @attributes - Value:
16
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Inch
Item #2 - Size - @attributes - Value:
16
Item #2 - Size Type:
Width
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Keep away from sunlight
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep dry
Item #3 - Storage Handling Type:
Special Storage Condition, Specify
Item #3 - Storage Handling Special Condition Text:
25C