CryoValve® SG Pulmonary Human Heart Valve SGPV10

GUDID 00877234000454

Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.

Cryolife, Inc.

Cadaveric heart valve prosthesis, decellularized, non-sterile
Primary Device ID00877234000454
NIH Device Record Keya8883b37-cc16-4a84-ada3-bf4b493723cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryoValve® SG Pulmonary Human Heart Valve
Version Model NumberSGPV10
Catalog NumberSGPV10
Company DUNS119253177
Company NameCryolife, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-419-3355
Emailxxx@xx.xx
Phone770-419-3355
Emailxxx@xx.xx

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *At or Below -135 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *At or Below -135 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100877234000454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OHAHeart Valve, More Than Minimally Manipulated Allograft

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-24
Device Publish Date2015-09-11

On-Brand Devices [CryoValve® SG Pulmonary Human Heart Valve ]

00877234000454Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptical
00877234000447Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart val

Trademark Results [CryoValve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRYOVALVE
CRYOVALVE
74104979 1719303 Live/Registered
CRYOLIFE, INC.
1990-10-09

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