KYPHON Express II KyphoPak Tray

GUDID 00763000026967

BONE TAMP KIT KEX202NB AF E2 20/2

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit
Primary Device ID00763000026967
NIH Device Record Keye20b584d-7c98-40ab-b613-d0fbfa473aae
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON Express II KyphoPak Tray
Version Model NumberKEX202NB
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 (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000026967 [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 Date2019-02-27
Device Publish Date2019-01-27

On-Brand Devices [KYPHON Express II KyphoPak Tray]

00763000026967BONE TAMP KIT KEX202NB AF E2 20/2
00763000026943BONE TAMP KIT KEX202EB FF E2 20/2 OI
00763000026936BONE TAMP KIT KEX152NB AF E2 15/2
00763000026912BONE TAMP KIT KEX152EB FF E2 15/2 OI
00763000026905BONE TAMP KIT KEX102NB AF E2 10/2
00763000026882BONE TAMP KIT KEX102EB FF E2 10/2 OI

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