MNAV FIDUCIAL MARKERS

GUDID 10815212026673

FIDUCIAL MARKERS AND SKIN MARKER PEN

Izi Medical Products, LLC

Radiological image marker, noninvasive, single-use
Primary Device ID10815212026673
NIH Device Record Key560ec20c-34c5-4aaa-9dcd-392f1c6ac29b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMNAV FIDUCIAL MARKERS
Version Model Number960-991
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 Datetrue
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
GS100815212020261 [Previous]
GS100815212026676 [Primary]
GS110815212026673 [Package]
Contains: 00815212026676
Package: Bag [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-24
Device Publish Date2023-11-16

Devices Manufactured by Izi Medical Products, LLC

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00815212026911 - KIT:BALLOON AND BONE FILLER2024-09-05
00815212026928 - KIT:BALLOON,FILLER,ACCESS,DRILL2024-09-05
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

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