AGILE - AGILE is sterile, single use conformable - MILLIKEN HEALTHCARE PDTS, LLC

Duns Number:963905539

Device Description: AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell t AGILE is 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/ lyocel 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.

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More Product Details

Catalog Number

3000119993

Brand Name

AGILE

Version/Model Number

4"x10"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Device Record Status

Public Device Record Key

9df54c94-3aa2-45e1-8ad1-0a06109ea7dd

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

February 04, 2021

Additional Identifiers

Package DI Number

10015961687105

Quantity per Package

2

Contains DI Package

00015961687108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box

"MILLIKEN HEALTHCARE PDTS, LLC" Characteristics
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