AccessGUDID - DEVICE: Gel-Block™ 10x Embolization Pledgets (M20636400)

GUDID

Device Identifier (DI) Information

Brand Name: Gel-Block™ 10x Embolization Pledgets
Version or Model: 3640
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20636400
Issuing Agency: HIBCC
Commercial Distribution End Date: September 04, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *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):	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?
60892	Non-neurovascular embolization plug, animal-derived	A bioabsorbable preformed device made from animal-derived (e.g., porcine) materials intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.	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 [?]
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
Device Size Text, specify: Maximum Swelled Diameter of Pledget 5 mm
Device Size Text, specify: Pledget Length 0.5 cm

Device Record Status

Public Device Record Key: a5e718dd-98ba-4e0e-823b-e37e2ef34419
Public Version Date: June 06, 2023
Public Version Number: 6
DI Record Publish Date: October 23, 2015