ULTRA Border - ULTRA Border is a sterile, single use gentle - MILLIKEN HEALTHCARE PDTS, LLC

Duns Number:963905539

Device Description: ULTRA Border is a sterile, single use gentle adhesive foam wound dressing. ULTRA border is ULTRA Border is a sterile, single use gentle adhesive foam wound dressing. ULTRA border is indicated for low to highly exuding acute and chronic wounds such as partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV pressure ulcers, venous ulcers, and diabetic ulcers. The dressing has a gentle silicone border, a polyester/ nylon wound contact layer, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with"Milliken" above and "ULTRA" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.

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More Product Details

Catalog Number

3000116877

Brand Name

ULTRA Border

Version/Model Number

3"x3"

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

3a97eccc-fa19-4f3c-89f8-f1e6bc0fb46e

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

January 06, 2021

Additional Identifiers

Package DI Number

20015961669191

Quantity per Package

10

Contains DI Package

10015961669194

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case

"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