Osteo-site Vertebral Augmentation Introducer 11G

GUDID 00815212024559

Izi Medical Products, LLC

Balloon kyphoplasty kit
Primary Device ID00815212024559
NIH Device Record Key2387fd66-c2ff-4f2e-8551-784c8a8c4065
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteo-site Vertebral Augmentation Introducer 11G
Version Model NumberVA1112
Company DUNS933506164
Company NameIzi Medical Products, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815212024559 [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 Date2020-09-04
Device Publish Date2020-08-27

Devices Manufactured by Izi Medical Products, LLC

10815212026895 - OsteoPearl Vertebral Balloon (15mm), 10G2024-08-13
00815212026904 - OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G2024-08-13
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
00815212026867 - MDT NAVIGATED BIOPSY, COMPATIABLE 7D2024-03-26
00815212026812 - ONPOINT NAVIGATION KIT2024-03-06
00815212026829 - ONPOINT NAVIGATION TRAY2024-03-06

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