ULTRA Border 3000116878

GUDID 10015961669217

ULTRA Border is a sterile, single use gentle adhesive foam wound dressing. ULTRA 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.

MILLIKEN HEALTHCARE PDTS, LLC

Exudate-absorbent dressing, non-gel, non-antimicrobial

• Primary Device ID: 10015961669217
• NIH Device Record Key: f5ad103e-bbb0-4d33-a388-edb2075d353d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA Border
• Version Model Number: 4"x4"
• Catalog Number: 3000116878
• Company DUNS: 963905539
• Company Name: MILLIKEN HEALTHCARE PDTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch
• Area/Surface Area: 16 Square inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015961669210 [Primary]
GS1	10015961669217 [Package]; Contains: 00015961669210; Package: Shelf box [10 Units]; In Commercial Distribution
GS1	20015961669214 [Package]; Package: Shipper box [10 Units]; In Commercial Distribution

FDA Product Code

• NAD: Dressing, Wound, Occlusive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-14
• Device Publish Date: 2021-01-06

On-Brand Devices [ULTRA Border ]

• 10015961669224: ULTRA is a sterile, single use gentle adhesive foam wound dressing. ULTRA is indicated for low t
• 10015961669217: ULTRA Border is a sterile, single use gentle adhesive foam wound dressing. ULTRA is indicated fo
• 20015961669207: ULTRA Border is a sterile, single use gentle adhesive foam wound dressing. ULTRA Border is indic
• 20015961669191: ULTRA Border is a sterile, single use gentle adhesive foam wound dressing. ULTRA border is indic