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.
Catalog Number
3000116880
Brand Name
ULTRA Border
Version/Model Number
4"x10"
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
20a4e3b4-4b0b-4290-b75f-a0676b399356
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
January 06, 2021
Package DI Number
20015961669207
Quantity per Package
10
Contains DI Package
10015961669200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper case
| 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 |