Balloon Kyphoplasty Essentials Kit

GUDID 00643169703506

KIT NH103PB 10/3 SPINE ESSEN FF

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit
Primary Device ID00643169703506
NIH Device Record Key0a22c469-79a7-4cbb-bb1b-5f87bb76117d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalloon Kyphoplasty Essentials Kit
Version Model NumberNH103PB
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
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 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169703506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

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 Date2017-05-15

On-Brand Devices [Balloon Kyphoplasty Essentials Kit]

00643169703599KIT NH152PB-CDS 15/2 SPINE ESSEN FF CDS
00643169703582KIT NH102PB-CDS 10/2 SPINE ESSEN FF CDS
00643169703575KIT NH203PB-CDS 20/3 SPINE ESSEN FF CDS
00643169703568KIT NH153PB-CDS 15/3 SPINE ESSEN FF CDS
00643169703551KIT NH103PB-CDS 10/3 SPINE ESSEN FF CDS
00643169703544KIT NH152PB 15/2 SPINE ESSEN FF
00643169703537KIT NH102PB 10/2 SPINE ESSEN FF
00643169703520KIT NH203PB 20/3 SPINE ESSEN FF
00643169703513KIT NH153PB 15/3 SPINE ESSEN FF
00643169703506KIT NH103PB 10/3 SPINE ESSEN FF

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