DEVICE: Cordis ExoSeal Vascular Closure Device (10705032058858)
Device Identifier (DI) Information
Cordis ExoSeal Vascular Closure Device
EX600
In Commercial Distribution
EX600
CORDIS CORPORATION
EX600
In Commercial Distribution
EX600
CORDIS CORPORATION
No description.
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58871 | Femoral artery closure plug/patch, synthetic polymer |
An 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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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MGB | DEVICE, HEMOSTASIS, VASCULAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry |
Special Storage Condition, Specify: Do not use if package is damaged |
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cf564b9d-7a04-4c73-a23f-3d990257f515
May 12, 2025
11
September 19, 2014
May 12, 2025
11
September 19, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20705032058855 | 5 | 10705032058858 | In Commercial Distribution | BOX | |
30705032058852 | 2 | 20705032058855 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined