Surface Applicator Cone, 35 mm SK1035

GUDID 00858012005632

Surface Applicator Cone, 35mm

Icad, Inc.

Intraoperative/postoperative therapeutic x-ray system surface applicator
Primary Device ID00858012005632
NIH Device Record Keyc4d92d6a-f587-4752-96e6-4191bebec5a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurface Applicator Cone, 35 mm
Version Model Number711109
Catalog NumberSK1035
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
GS100858012005632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JADSystem, Therapeutic, X-Ray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858012005632]

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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