Nucleotome 11000

GUDID B067110000

Nucleotome Console

CLARUS MEDICAL, LLC

Surgical power tool system control unit, pneumatic
Primary Device IDB067110000
NIH Device Record Keyd40491a8-7ed4-4a3f-b3ee-546fe4ea3d7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNucleotome
Version Model Number11000
Catalog Number11000
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
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 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

Customer Support Contacts

Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 98 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 98 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB067110000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [Nucleotome]

B0672353513.5 MM Kit with aspiration bottle
B0672350012.5 MM Kit with aspiration bottle
B0672250012.0 MM Kit with aspiration bottle
B0672120012.0 MM Short Kit with aspiration bottle
B067110000Nucleotome Console

Trademark Results [Nucleotome]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NUCLEOTOME
NUCLEOTOME
73667083 1480701 Dead/Cancelled
SURGICAL DYNAMICS, INC.
1987-06-18
NUCLEOTOME
NUCLEOTOME
73512585 1383244 Live/Registered
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
1984-12-07

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