Nucleotome 22500

GUDID B067225001

2.0 MM Kit with aspiration bottle

CLARUS MEDICAL, LLC

Diskectomy system, percutaneous, automatic
Primary Device IDB067225001
NIH Device Record Key5ae9555d-6b9c-4f86-a7cd-56b5163ea2b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNucleotome
Version Model Number22500
Catalog Number22500
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Outer Diameter2 Millimeter
Outer Diameter2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB067225000 [Unit of Use]
HIBCCB067225001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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