AccessGUDID - DEVICE: Occlusin 500 (07540270000049)

GUDID

Device Identifier (DI) Information

Brand Name: Occlusin 500
Version or Model: Ekobi 503P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMBiotechnologies Ltd

Primary DI Number: 07540270000049
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 244234295 *Terms of Use

Device Description: Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of calibrated sizes. The poly-DL-lactic-co-glycolic acid (PLGA) microspheres are surface-coated with bovine collagen. Following injection, the collagen binds patient platelets resulting in a platelet-rich clot which occludes the vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months.

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):	Yes
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?
59048	Embolization particle, bioabsorbable	A bioabsorbable, implantable bead/microsphere intended to be used to temporarily occlude an artery supplying hyperplastic/neoplastic tissue in a variety of anatomies (e.g., liver, lung, breast, bladder, uterus, head or neck); it does not include a pharmaceutical agent. It may be used independently to create ischemia in the tissue, or as an adjuvant in combination with cytostatic agents and other antitumour drugs to help optimize intra-tumour drug accumulation for interventional radiology and visceral surgery procedures. It is typically available as an injectable solution containing numerous microspheres [e.g., degradable starch microspheres (DSM)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRD	Device, Vascular, For Promoting Embolization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093813	000

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
Special Storage Condition, Specify: Store in a cool, dry location

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 150-180 µm

Device Record Status

Public Device Record Key: 7f4412a2-61f4-4e89-815c-607505ee24bc
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: January 24, 2019