MILLIKEN HEALTHCARE PDTS, LLC

Address:920 Milliken Rd,SPARTANBURG,SC,29303,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Dressing, Wound, Hydrophilic (NAC) (3)

Premarket Exempt

No Yes

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AGILE - 00015961687085 Catalog Number : 3000119991

Device Description : AGILE is a sterile, single-use conformable multi-layered wound dressing containi 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.

Device Class :

Duns Number: 963905539

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

AGILE - 00015961687092 Catalog Number : 3000119992

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

Device Class :

Duns Number: 963905539

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

AGILE - 00015961687108 Catalog Number : 3000119993

Device Class :

Duns Number: 963905539

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

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