Prytime Medical Devices, Inc.

GUDID 00850001105118

pREBOA-PRO Balloon Occlusion Catheter

Prytime Medical Devices, Inc.

Intravascular occluding balloon catheter, image-guided
Primary Device ID00850001105118
NIH Device Record Keyba71270a-b444-4bab-af24-9875c712d71f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrytime Medical Devices, Inc.
Version Model NumberPRP7226M
Company DUNS050741500
Company NamePrytime Medical Devices, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001105118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-30
Device Publish Date2025-06-20

On-Brand Devices [Prytime Medical Devices, Inc.]

00863092000101REBOA Catheter Convenience Set
00850001105064pREBOA-PRO Balloon Occlusion Catheter
00850001105125REBOA Catheter Compass Convenience Set
00850001105118pREBOA-PRO Balloon Occlusion Catheter

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