DEVICE: Angio-Seal™ (05415067002853)

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Device Identifier (DI) Information

Angio-Seal™
VIP
610131
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
05415067002853
GS1
1
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 compression plug, collagen A sterile, implantable, bioabsorbable device designed to provide compression for haemostasis to the 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 haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable anchor/suture to achieve haemostasis.
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FDA Product Code

[?]
Product Code Product Code Name
MGB DEVICE, HEMOSTASIS, VASCULAR
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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: 8 French
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Device Status

Not in Commercial Distribution
October 24, 2014
April 20, 2017
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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
25415067002857 5 05415067002853 2017-04-20 Not in Commercial Distribution
15415067002850 2 25415067002857 2017-04-20 Not in Commercial Distribution
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Secondary DI

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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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