Balloon Applicator Kit AB2063E

GUDID 00858012005342

Balloon Applicator, 5x7 cm Ellipsodial

Icad, Inc.

Intraoperative/postoperative therapeutic x-ray system balloon applicator kit
Primary Device ID00858012005342
NIH Device Record Key787da7e0-42b8-4ac4-a9d1-0ec2c92e7296
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalloon Applicator Kit
Version Model Number720343
Catalog NumberAB2063E
Company DUNS108870254
Company NameIcad, 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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JADSystem, Therapeutic, X-Ray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [Balloon Applicator Kit]

00858012005342Balloon Applicator, 5x7 cm Ellipsodial
00858012005335Balloon Applicator, 5-6 cm Spherical
00858012005328Balloon Applicator, 4-5 cm Spherical
00858012005311Balloon Applicator, 3-4 cm Spherical

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