FDA UDI
In Commercial Distribution
🇺🇸 United States
PhotoFix Decellularized Bovine Pericardium
DI: 00877234000522
·
Model: PFP 6x8
·
Artivion, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PhotoFix Decellularized Bovine Pericardium
- Primary DI
- 00877234000522
- Version / Model
- PFP 6x8
- Catalog Number
- PFP 6x8
- Company Name
- Artivion, Inc.
- Labeler DUNS
- 119253177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-03
- Public Version
- 4
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- c8646337-5691-4e8b-b7a5-6f4d956ae425
Device Description
Decellularized Bovine Pericardium
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 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 |
|---|---|---|---|---|---|---|
| Primary | 00877234000522 | GS1 | ||||
| Previous | B040PFP6X81 | HIBCC |
Customer Contacts
- Phone
- 800-438-8285
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6 | Centimeter | |
| Length | 8 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not place the pericardium in areas where significant temperature fluctuations occur.
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius