DEVICE: SJM™ (05414734054881)

Download: XML | JSON

Device Identifier (DI) Information

SJM™
Pericardial Patch
C0405
ST. JUDE MEDICAL, INC.
05414734054881
GS1
1
With EnCap™ Technology
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cardiovascular patch, animal-derived A sterile 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DXZ PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 0 and 100 Percent (%) Relative Humidity
Handling Environment Humidity: between 0 and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 25.33 and 101.33 KiloPascal
Handling Environment Atmospheric Pressure: between 25.33 and 101.33 KiloPascal
Handling Environment Temperature: between 0 and 45 Degrees Celsius
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Special Storage Condition, Specify: Do not use if package is damaged. Do not resterilize.
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 5 Centimeter
Width: 4 Centimeter
CLOSE

Device Status

In Commercial Distribution
April 19, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
CLOSE