Pro-Tec II 5 cc 007-901

GUDID 00859942006522

Tungsten Syringe Shield

CAPINTEC, INC.

Syringe radiation shield
Primary Device ID00859942006522
NIH Device Record Key7e2b05ff-d046-4f42-b4ba-f2ba76074ac1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro-Tec II 5 cc
Version Model Number007-901
Catalog Number007-901
Company DUNS047684501
Company NameCAPINTEC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com
Phone201-825-9500
Emailflo-techsupport@mirion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859942006522 [Primary]

FDA Product Code

IWRHolder, Syringe, Lead

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-19
Device Publish Date2022-07-11

Devices Manufactured by CAPINTEC, INC.

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00879942070118 - AeroTech I Convenience Kit, Standard2022-08-16 AeroTech I Convenience Kit, Standard part of Radioaerosol Administration System
00879942070132 - AeroTech I Convenience Kit, Venti Pak 2022-08-16 AeroTech I Convenience Kit, Venti Pak, for Radioaerosol Administration System
00879942070149 - Venti-Scan IV Shield2022-08-16 Venti-Scan IV Shield, part of Radioaerosol Administration System
00879942070156 - Venti-Scan IV Convenience Kit, 24 inch tubing2022-08-16 Venti-Scan IV Convenience Kit, 24 inch tubing, part of Radioaerosol Administration System
00879942070163 - Venti-Scan IV Convenience Kit, Venti Pak2022-08-16 Venti-Scan IV Convenience Kit, Venti Pak, part of Radioaerosol Administration System
00879942070170 - Venti-Scan IV Convenience Kit, 12 inch tubing2022-08-16 Venti-Scan IV Convenience Kit, 12 inch tubing, for Radioaerosol Administration System

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