HyperForm 104-4420

GUDID 00836462004665

Occlusion Balloon System

Micro Therapeutics, Inc.

Intravascular occluding balloon catheter, image-guided
Primary Device ID00836462004665
NIH Device Record Key6e859402-4236-43d2-b86f-8c9a85cd3ec9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyperForm
Version Model Number104-4420
Catalog Number104-4420
Company DUNS826110710
Company NameMicro Therapeutics, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS100836462004665 [Primary]

FDA Product Code

MJNCatheter, intravascular occluding, temporary

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-21
Device Publish Date2015-10-06

On-Brand Devices [HyperForm]

00836462004689Occlusion Balloon System
00836462004665Occlusion Balloon System
00836462004641Occlusion Balloon System
00836462004627Occlusion Balloon System
00836462004603Occlusion Balloon System
00836462004207Occlusion Balloon System
00836462004184Occlusion Balloon System
00763000294328BALLOON SYSTEM 104-4770 V20 HYPERFORM
00763000294298BALLOON SYSTEM 104-4715 V20 HYPERFORM
00763000294267BALLOON SYSTEM 104-4470 V20 HYPERFORM
00763000294236BALLOON SYSTEM 104-4420 V20 HYPERFORM
00763000294205BALLOON SYSTEM 104-4415 V20 HYPERFORM
00763000294175BALLOON SYSTEM 104-4370 V20 HYPERFORM
00763000294144BALLOON SYSTEM 104-4153 V20 HYPERFORM

Trademark Results [HyperForm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYPERFORM
HYPERFORM
98045915 not registered Live/Pending
WestRock Shared Services, LLC
2023-06-16
HYPERFORM
HYPERFORM
90351532 not registered Live/Pending
Covidien LP
2020-12-01
HYPERFORM
HYPERFORM
88922237 not registered Live/Pending
Bushwacker, Inc.
2020-05-19
HYPERFORM
HYPERFORM
87935263 5665831 Live/Registered
QUADEX, LLC
2018-05-24
HYPERFORM
HYPERFORM
87095952 not registered Dead/Abandoned
HyperGrid, Inc.
2016-07-07
HYPERFORM
HYPERFORM
86127058 4571520 Live/Registered
Wirerope Works, Inc.
2013-11-22
HYPERFORM
HYPERFORM
85660097 4286019 Live/Registered
Milliken & Company
2012-06-25
HYPERFORM
HYPERFORM
85414871 4455492 Live/Registered
Hygenic Intangible Property Holding Co.
2011-09-04
HYPERFORM
HYPERFORM
78140290 not registered Dead/Abandoned
Hessville Cable & Sling Company
2002-07-01
HYPERFORM
HYPERFORM
78080325 2647381 Live/Registered
Milliken & Company
2001-08-21
HYPERFORM
HYPERFORM
76427046 2818889 Dead/Cancelled
HYGENIC INTANGIBLE PROPERTY HOLDING CO.
2002-07-02
HYPERFORM
HYPERFORM
76248694 not registered Dead/Abandoned
WIREROPE WORKS, INC.
2001-04-27
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.