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Elutia Med LLC CMCV-124-LRG EluPro Antibiotic-Eluting BioEnvelope

Company Name

Elutia Med LLC

Catalog Number

CMCV-124-LRG

Device Size

Large

Description

The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.

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Additional Details

Device Identifier

00859389005348

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

Yes

Is Single Use

Yes

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	00859389005348
Box of 5	5	10859389005345