BKP-10-12.0-15.0

GUDID 00815212024535

Izi Medical Products, LLC

Balloon kyphoplasty kit
Primary Device ID00815212024535
NIH Device Record Key4b7cd2d6-4bf1-4022-9461-ee64bdfbe37f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBKP-10-12.0-15.0
Version Model NumberG10015
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 Datefalse
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
GS100815212024535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-03
Device Publish Date2020-08-26

Devices Manufactured by Izi Medical Products, LLC

00815212026935 - Duro-Ject Bone Cement Injection Tube2024-10-22
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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