EluPro Antibiotic-Eluting BioEnvelope
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Basic Information
- Brand Name
- EluPro Antibiotic-Eluting BioEnvelope
- Primary DI
- 00859389005348
- Version / Model
- CMCV-124-LRG
- Company Name
- Elutia Med LLC
- Labeler DUNS
- 080924060
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-06
- Public Version
- 3
- Public Version Date
- 2025-12-17
- Public Version Status
- Update
- Public Device Record Key
- 42c2bb1f-d06c-4183-b834-bb0c78a0cef2
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTM | Mesh, Surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35273 | Cardiovascular patch, animal-derived | An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859389005348 | GS1 | ||||
| Package | 10859389005345 | GS1 | Box | 5 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Large |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius