FISH 6 Fr CombiClose Vascular Closure Device

Basic Information

• Brand Name: FISH 6 Fr CombiClose Vascular Closure Device
• Primary DI: 00858241005014
• Version / Model: 16-06-01-S
• Company Name: MORRIS INNOVATIVE, INC.
• Labeler DUNS: 005036225
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-16
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: d1347f75-cc9b-4ac4-a66f-265e29e2bfad

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858241005014	GS1