FDA UDI
In Commercial Distribution
🇺🇸 United States
CryoPatch® SG Pulmonary Human Cardiac Trunk Patch
DI: 00877234000478
·
Model: SGP010
·
Artivion, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CryoPatch® SG Pulmonary Human Cardiac Trunk Patch
- Primary DI
- 00877234000478
- Version / Model
- SGP010
- Catalog Number
- SGP010
- Company Name
- Artivion, Inc.
- Labeler DUNS
- 119253177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-11
- Public Version
- 6
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 8b36a2c4-0ae9-4ef5-b2e7-7d57c34d9609
Device Description
CryoPatch SG Pulmonary Trunk The CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 61625 | Cadaveric pulmonary artery bioprosthesis | An implantable heart tissue allograft obtained from a human cadaver intended to be implanted in the heart during open heart surgery, to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularized. It may be supplied in various configurations including pulmonary hemi-artery, pulmonary trunk and pulmonary branch. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00877234000478 | GS1 |
Customer Contacts
- Phone
- 770-419-3355
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101866 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Width: 3.0cm (minimum)(allograft specific) | ||
| Device Size Text, specify | Length: 12.5cm (minimum)(allograft specific) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- At or Below -135 degrees Celsius