Surface Applicator Set Bundle 1 SK1001

GUDID 00858012005359

Surface Applicator Bundle

Icad, Inc.

Intraoperative/postoperative therapeutic x-ray system surface applicator
Primary Device ID00858012005359
NIH Device Record Key14694fa3-664e-4a36-a712-9cfad40189de
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurface Applicator Set Bundle 1
Version Model Number720314
Catalog NumberSK1001
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JADSystem, Therapeutic, X-Ray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858012005359]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

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