FDA UDI
In Commercial Distribution
🇺🇸 United States
ProxiCor for Pericardial Closure
DI: 00859389005010
·
Model: CMCV-060-402
·
AZIYO BIOLOGICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ProxiCor for Pericardial Closure
- Primary DI
- 00859389005010
- Version / Model
- CMCV-060-402
- Company Name
- AZIYO BIOLOGICS, INC.
- Labeler DUNS
- 080251450
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-06-30
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- abd70a9b-3877-4ffe-827b-81eba73791c6
Device Description
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | Cardiovascular | 870.3470 | 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 |
|---|---|---|---|---|---|---|
| Package | 10859389005017 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 00859389005010 | GS1 |
Customer Contacts
- Phone
- 470-514-4080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051405 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 7.0 | Centimeter | |
| Height | 15.0 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius