DEVICE: Cordis ExoSeal Vascular Closure Device (10705032058872)

Device Identifier (DI) Information

Cordis ExoSeal Vascular Closure Device
EX500
In Commercial Distribution
EX500
CORDIS CORPORATION
10705032058872
GS1

1
806136177 *Terms of Use
No description.
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Device Characteristics

MR Conditional
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, synthetic polymer A sterile, implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of a bioabsorbable synthetic polymer plug and/or patch [e.g., polyglycolic acid (PGA)] that is implanted 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 [?]
P100013 010
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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
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Do not use if package is damaged
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4eb4f0d7-524d-4929-8c84-93d567fdc279
October 22, 2018
5
September 19, 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
20705032058879 10 10705032058872 In Commercial Distribution BOX
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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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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