Novatome

GUDID 00866215000064

SCHOLTEN SURGICAL INSTRUMENTS, INC.

Endomyocardial biopsy forceps, single-use
Primary Device ID00866215000064
NIH Device Record Key155709fa-3794-4c80-8953-ec5fc76e442f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovatome
Version Model NumberSU103-100PC
Company DUNS130178346
Company NameSCHOLTEN SURGICAL INSTRUMENTS, 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 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

Phone866-452-3525
Emailjimv@novatome.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866215000064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWZDevice, Biopsy, Endomyocardial

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-29
Device Publish Date2016-09-06

On-Brand Devices [Novatome]

00866215000064SU103-100PC
00866215000057SU103-100
00866215000040SU104-100
00866215000033SU104-50
00866215000026SU103-50
00866215000019SU102-50
00866215000002SU101-50

Trademark Results [Novatome]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVATOME
NOVATOME
85250585 4120614 Dead/Cancelled
Scholten Surgical Instruments, Inc.
2011-02-24
NOVATOME
NOVATOME
77175418 not registered Dead/Abandoned
Scholten Surgical Instruments, Inc.
2007-05-08
NOVATOME
NOVATOME
73252553 1214526 Dead/Expired
Novatome, S.A.
1980-03-04

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