DEVICE: Angio-Seal™ (05414734054591)

Device Identifier (DI) Information

Angio-Seal™
VIP
Not in Commercial Distribution
610130
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
05414734054591
GS1
April 20, 2017
1
040960379 *Terms of Use
No description.
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Device Characteristics

MR Safe
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
Femoral artery closure plug/patch, collagen A sterile, implantable, bioabsorbable device designed for pressure haemostasis/closure of a puncture site on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression techniques to reduce the time to heamostasis. It consists of an animal-derived collagen plug/patch [e.g., polyglycolic acid (PGA)] that is implanted, using an included delivery device(s), onto the extravascular (plug-like) and/or intravascular (patch-like) surface of the femoral artery access site. Delivery device(s) dedicated to implant introduction [i.e., not intended to allow access for other devices (catheters)] are typically included.
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FDA Product Code

[?]
Product Code Product Code Name
MGB DEVICE, HEMOSTASIS, VASCULAR
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 6 French
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Device Record Status

00b10b72-1f70-4274-bbea-06e3b23ea800
October 05, 2018
3
October 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15414734054598 5 05414734054591 2017-04-20 Not in Commercial Distribution
05414734054607 2 15414734054598 2017-04-20 Not in Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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