FDA UDI
In Commercial Distribution
🇺🇸 United States
CryoValve® SG Pulmonary Human Heart Valve
DI: 00877234000447
·
Model: SGPV00
·
Artivion, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CryoValve® SG Pulmonary Human Heart Valve
- Primary DI
- 00877234000447
- Version / Model
- SGPV00
- Catalog Number
- SGPV00
- 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
- 5
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 4c4920bc-1260-4e9e-905c-831bbbf0e84a
Device Description
Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve 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 |
|---|---|---|---|---|
| OHA | Heart Valve, More Than Minimally Manipulated Allograft | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61626 | Cadaveric heart valve prosthesis, decellularized, non-sterile | A non-sterile, implantable, allograft heart valve obtained from a human cadaver intended to be used to repair or replace a dysfunctional native or prosthetic heart valve in a patient. It is aseptically processed and treated to render the tissue decellularized. The device is typically used to treat acquired or congenital valvular disease and not intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00877234000447 | GS1 |
Customer Contacts
- Phone
- 770-419-3355
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092021 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Internal Diameter: Ranges from 6mm to 32mm (allograft specific) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- At or Below -135 degrees Celsius