HydroPearl HP2S0075

GUDID 00816777026088

Bland Beads

MICROVENTION INC.

Embolization particle, non-bioabsorbable
Primary Device ID00816777026088
NIH Device Record Keyd18b12c4-8b24-4ffe-bce9-95a885860742
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydroPearl
Version Model NumberHP2S0075
Catalog NumberHP2S0075
Company DUNS003263105
Company NameMICROVENTION INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Customer Support Contacts

Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100816777026088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NAJAgents, embolic, for treatment of uterine fibroids

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-07
Device Publish Date2018-08-07

On-Brand Devices [HydroPearl]

00812636020655Bland Beads
00812636020648Bland Beads
00812636020631Bland Beads
00812636020624Bland Beads
00812636020617Bland Beads
00816777026132Bland Beads
00816777026125Bland Beads
00816777026118Bland Beads
00816777026101Bland Beads
00816777026095Bland Beads
00816777026088Bland Beads
00812636020662Bland Beads

Trademark Results [HydroPearl]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYDROPEARL
HYDROPEARL
87652384 not registered Live/Pending
Troy Technology II, Inc.
2017-10-19
HYDROPEARL
HYDROPEARL
85835079 4509131 Live/Registered
Terumo Kabushiki Kaisha
2013-01-29

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