AccessGUDID - DEVICE: FISH 8 Fr CombiClose Vascular Closure Device (00858241005038)

GUDID

Device Identifier (DI) Information

Brand Name: FISH 8 Fr CombiClose Vascular Closure Device
Version or Model: 16-08-01-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MORRIS INNOVATIVE, INC.

Primary DI Number: 00858241005038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036225 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63620	Femoral artery catheter introduction/wound closure set	A collection of invasive devices intended to: 1) provide percutaneous femoral artery access to enable introduction of a catheter (not included) into the vascular system; and 2) plug the femoral artery puncture site following catheterization to provide haemostasis. It includes a non-steerable introducer sheath assembly (introducer sheath with e.g., obturator/dilator, guidewire) with an integrated bioabsorbable, animal-derived, implantable, femoral artery compression plug, typically with a synthetic deployment suture/cord. Prior to removal of the introducer assembly the plug is deployed. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 84d0893d-56ec-45ea-ad81-effe2762a6f5
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: September 16, 2014