Sierra Summit

GUDID 00840067102848

SUMMIT ER-3C INSERT EARPHONE CABLE

CADWELL INDUSTRIES, INC.

Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph
Primary Device ID00840067102848
NIH Device Record Key3f3627d3-1790-4f1f-bc1f-f9de93d3eb76
Commercial Distribution StatusIn Commercial Distribution
Brand NameSierra Summit
Version Model Number199295-200
Company DUNS098554157
Company NameCADWELL INDUSTRIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067102848 [Primary]

FDA Product Code

OLVStandard polysomnograph with electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-18
Device Publish Date2020-12-10

On-Brand Devices [Sierra Summit]

00840067100103Sierra Summit 2 Ch. Amplifier
00840067100325Sierra Summit Bone Vibrator
00840067100301Sierra Summit Remote Input Box
00840067100288VEP Cal Sensor
00840067100264RING/BAR ELECTRODE SWITCH BOX
00840067100097Sierra Summit 12 Ch. Amplifier
00840067100035Sierra Summit Base
00840067100011Sierra Summit StimTroller Plus
00840067102848SUMMIT ER-3C INSERT EARPHONE CABLE

Trademark Results [Sierra Summit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIERRA SUMMIT
SIERRA SUMMIT
90360422 not registered Live/Pending
Cadwell Industries, Inc.
2020-12-04
SIERRA SUMMIT
SIERRA SUMMIT
77058933 3491058 Dead/Cancelled
Sierra Summit Inc.
2006-12-07

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