Rad Control

GUDID 00892159002154

15 Gy Irradiation Indicator Tag - Gamma

TYPENEX MEDICAL LLC

Blood irradiation indicator
Primary Device ID00892159002154
NIH Device Record Key6b22f1f0-3c6f-4064-b072-4c4efd9c4b3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRad Control
Version Model NumberRT0102
Company DUNS600850213
Company NameTYPENEX MEDICAL LLC
Device Count200
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100810050855099 [Unit of Use]
GS100892159002154 [Primary]

FDA Product Code

IWZFilm, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-01
Device Publish Date2022-11-23

On-Brand Devices [Rad Control]

0089215900217815 Gy Irradiation Indicator Tag - X Ray
0089215900216125 Gy Irradiation Indicator Tag - X Ray
0089215900215415 Gy Irradiation Indicator Tag - Gamma
0089215900210925 Gy Irradiation Indicator Tag - Gamma
0085187800889225 Gy Irradiation Indicator Tag - X Ray - Custom One Blood
0085187800888525 Gy Irradiation Indicator Tag - Gamma - Custom One Blood
00812269033374Irradiation Indicator Tag - Barcode Indicator
0081226903335025 - 50 GY Irradiation Indicator Tag
0081226903334315 - 50 GY Irradiation Indicator Tag
0081226903001425 Gy Irradiation Indicator Tag - X Ray (no sticker)
0081226903000725 Gy Irradiation Indicator Tag - Gamma (No Sticker)
0081005085564825 Gy Universal Irradiation Tag (RT0301XVT)

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