One-Step™ Osteo Introducer® System; CDS and BFD

GUDID 00763000557133

KIT KPX153PB-CDS-A 15/3 FF 1-STEP W CDS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit
Primary Device ID00763000557133
NIH Device Record Key0188d623-4b8d-4c7c-afe7-9d1a9c756661
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne-Step™ Osteo Introducer® System; CDS and BFD
Version Model NumberKPX153PB-CDS-A
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000557133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-17
Device Publish Date2021-08-09

On-Brand Devices [One-Step™ Osteo Introducer® System; CDS and BFD]

00763000557157KIT KPX203PB-CDS-A 20/3 FF 1-STEP W CDS
00763000557133KIT KPX153PB-CDS-A 15/3 FF 1-STEP W CDS
00763000557119KIT KPX103PB-CDS-A 10/3 FF 1-STEP W CDS

Trademark Results [One-Step]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONE-STEP
ONE-STEP
98274868 not registered Live/Pending
Helen of Troy Limited
2023-11-17
ONE-STEP
ONE-STEP
97399353 not registered Live/Pending
Louis M. Gerson Co., Inc.
2022-05-06
ONE-STEP
ONE-STEP
88881299 not registered Live/Pending
Merit Medical Systems, Inc.
2020-04-21
ONE-STEP
ONE-STEP
86966385 5073304 Live/Registered
DUNCAN ENTERPRISES
2016-04-06
ONE-STEP
ONE-STEP
86697248 5360382 Live/Registered
Avent, Inc.
2015-07-17
ONE-STEP
ONE-STEP
78856080 not registered Dead/Abandoned
GenScript Corporation
2006-04-06
ONE-STEP
ONE-STEP
78727522 not registered Dead/Abandoned
STAUF USA, LLC.
2005-10-06
ONE-STEP
ONE-STEP
78538477 not registered Dead/Abandoned
SDI Technologies, Inc.
2004-12-27
ONE-STEP
ONE-STEP
78236514 not registered Dead/Abandoned
Hectra-Life Products, Inc.
2003-04-11
ONE-STEP
ONE-STEP
78147570 2719496 Dead/Cancelled
MEDIPURPOSE PTE. LTD.
2002-07-25
ONE-STEP
ONE-STEP
78147350 2922552 Live/Registered
MEDIPURPOSE PTE. LTD.
2002-07-25
ONE-STEP
ONE-STEP
77921262 4113459 Live/Registered
Stauf USA, LLC
2010-01-27

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