AccessGUDID - DEVICE: Embozene Microspheres (Opaque) (00879397003310)

GUDID

Device Identifier (DI) Information

Brand Name: Embozene Microspheres (Opaque)
Version or Model: 14020-S0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CELONOVA BIOSCIENCES, INC.

Primary DI Number: 00879397003310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 168593429 *Terms of Use

Device Description: Microspheres for Embolization

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:	No
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?
60938	Embolization particle, non-bioabsorbable	A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NAJ	Agents,Embolic,For Treatment Of Uterine Fibroids
KRD	Device, Vascular, For Promoting Embolization

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
Outer Diameter: 400 Micrometer

Device Record Status

Public Device Record Key: 936a16fd-926b-40cb-bd3f-779eeda4d97b
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: July 15, 2015