Surface Applicator Cone, 50 mm SK1050

GUDID 00858012005649

Surface Applicator Cone, 50mm

Icad, Inc.

Intraoperative/postoperative therapeutic x-ray system surface applicator
Primary Device ID00858012005649
NIH Device Record Key00b3504b-65ab-487c-af9d-bb59641f0138
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurface Applicator Cone, 50 mm
Version Model Number711110
Catalog NumberSK1050
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
GS100858012005649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JADSystem, Therapeutic, X-Ray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858012005649]

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

Devices Manufactured by Icad, Inc.

00850008977527 - PowerLook 11.32023-08-10
00085000897751 - PowerLook Cloud 1.0 2023-07-25
00850008977442 - PowerLook 11.2 2023-07-24
00850008977459 - PowerLook Al Mammo Container - Radiology Partners v1.0.0 2023-07-24
00850008977466 - PowerLook Al Mammo Container- GE v1.1.0 2023-07-24
00850008977473 - PowerLook Al Mammo Container- Blackford v1.0.0 2023-07-24
00850008977480 - PowerLook Al Mammo Container- Ferrum v1.0.0 2023-07-24
00850008977497 - PowerLook Al Mammo Container - Arterys v 1.2.02023-07-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.