nView 627 Reflective Markers -14

GUDID 00815212026713

Reflective Markers -14

Izi Medical Products, LLC

Radiographic image marker, manual
Primary Device ID00815212026713
NIH Device Record Key0413765b-b7fd-4394-bce7-1459e0b321d0
Commercial Distribution StatusIn Commercial Distribution
Brand NamenView 627 Reflective Markers -14
Version Model Number627
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
GS100815212026713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-04
Device Publish Date2023-07-27

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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