AccessGUDID - DEVICE: Cordis ExoSeal Vascular Closure Device (10705032058858)

GUDID

Device Identifier (DI) Information

Brand Name: Cordis ExoSeal Vascular Closure Device
Version or Model: EX600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EX600
Company Name: CORDIS CORPORATION

Primary DI Number: 10705032058858
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806136177 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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 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 a bioabsorbable synthetic polymer plug/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.

GMDN Preferred Term Name

GMDN Definition

Femoral artery closure plug/patch, synthetic polymer

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 a bioabsorbable synthetic polymer plug/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.

FDA Product Code

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Product Code	Product Code Name
MGB	DEVICE, HEMOSTASIS, VASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100013	010

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf564b9d-7a04-4c73-a23f-3d990257f515
Public Version Date: October 05, 2018
Public Version Number: 4
DI Record Publish Date: September 19, 2014