Cyberwand USL Wrench

GUDID 00855279005313

CYBERSONICS INC

Surgical torque wrench, reusable
Primary Device ID00855279005313
NIH Device Record Keyb6727e29-4bed-4984-a578-1ed96ff63e9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyberwand USL Wrench
Version Model NumberCW-USLW
Company DUNS943561522
Company NameCYBERSONICS 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 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
GS100855279005313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFKLithotriptor, Electro-Hydraulic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


[00855279005313]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [Cyberwand USL Wrench]

00855279005313CW-USLW
H891CWUSLW2CW-USLW

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