CT Sim

GUDID B136A4100G0

GAMMEX, INC.

Laser patient positioning system Laser patient positioning system
Primary Device IDB136A4100G0
NIH Device Record Key67b22414-1aca-4751-b46f-134e52c2f139
Commercial Distribution Discontinuation2017-05-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCT Sim
Version Model Number805044
Company DUNS157308230
Company NameGAMMEX, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18004266391
Emailsales@gammex.com
Phone+18004266391
Emailsales@gammex.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB136A4100G0 [Primary]

FDA Product Code

IWEMonitor, Patient Position, Light-Beam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-26
Device Publish Date2016-09-23

On-Brand Devices [CT Sim]

B136A5000A0Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p
B136A4110G0Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p
B136A4100G0805044
B136A4010A0Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p
B136A3100G0Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p
B136A3000A0Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p

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