Kyphoplasty Bone Drill

GUDID 00815212024566

Izi Medical Products, LLC

Bone access cannula
Primary Device ID00815212024566
NIH Device Record Keyc1b955a2-f548-427e-be3e-2bb8f8c9a850
Commercial Distribution StatusIn Commercial Distribution
Brand NameKyphoplasty Bone Drill
Version Model NumberVA10BD
Company DUNS933506164
Company NameIzi Medical Products, LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815212024566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-25
Device Publish Date2021-10-15

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00815212024467 - STRYKER NAVIGATED BIOPSY NEEDLE2024-08-07
00815212026874 - BKP-10-12.0-15.0-A2024-07-08
00815212026881 - BKP-11-12.0-15.0-A2024-07-08

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