Safe-Cam Display Monitor Assembly SC-M

GUDID M710SCM0

BIOTEX, INC.

Rigid non-bladed video intubation laryngoscope
Primary Device IDM710SCM0
NIH Device Record Key82cb2398-550a-4026-8232-b71cbbde352a
Commercial Distribution Discontinuation2020-02-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSafe-Cam Display Monitor Assembly
Version Model Number033-6501
Catalog NumberSC-M
Company DUNS969792050
Company NameBIOTEX, 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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 540 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM710SCM0 [Primary]

FDA Product Code

CCWLaryngoscope, Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2018-07-25

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