Duns Number:963905539
Device Description: AGILE is a sterile, single-use conformable multi-layered wound dressing containing Lyocell AGILE is a sterile, single-use conformable multi-layered wound dressing containing Lyocell that provides moisture management and gelling fiber properties. AGILE is indicated for the management of acute and chronic wounds: partial-thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, tunneling, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). AGILE consists of a white polyester/ lyocell wound contact layer and two blue polyester/ lyocell waffle knit fabrics laminated together. The blue side of the dressing is placed away from the wound.
Catalog Number
3000119991
Brand Name
AGILE
Version/Model Number
2"x2"
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
c13b33ba-6c8d-419b-8e51-29d8076c0a9c
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
February 04, 2021
Package DI Number
10015961687082
Quantity per Package
10
Contains DI Package
00015961687085
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| U | Unclassified | 5 |