Cardion™

GUDID 00386190002087

for Pericardial Repair, 10 x 15 cm

ACELL, INC.

Multi-purpose surgical mesh, collagen, bioabsorbable
Primary Device ID00386190002087
NIH Device Record Keyc011bf21-1483-4705-8192-7b18f5208153
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardion™
Version Model NumberPP1015
Company DUNS137258252
Company NameACELL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com

Device Dimensions

Length15 Centimeter
Width10 Centimeter
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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry environment at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100386190002087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSQIntracardiac patch or pledget, biologically derived

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-10
Device Publish Date2020-07-31

On-Brand Devices [Cardion™]

00386190002087for Pericardial Repair, 10 x 15 cm
00386190002070for Pericardial Repair, 7 x 10 cm
00386190002063for Pericardial Repair, 7 x 15 cm

Trademark Results [Cardion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDION
CARDION
98303963 not registered Live/Pending
ACell, Inc.
2023-12-07
CARDION
CARDION
88795790 not registered Live/Pending
ACell, Inc.
2020-02-13
CARDION
CARDION
76030932 not registered Dead/Abandoned
CARDIOGENE GENTHERAPEUTISCHE SYSTEME AG
2000-04-19
CARDION
CARDION
73038725 1021954 Dead/Expired
GENERAL SIGNAL CORPORATION
1974-12-05
CARDION
CARDION
73038724 1021953 Dead/Expired
GENERAL SIGNAL CORPORATION
1974-12-05

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