Vacuum Bag

GUDID 00815212021121

Izi Medical Products, LLC

Vacuum-mould patient positioning system
Primary Device ID00815212021121
NIH Device Record Key4f5298ef-9f18-4b41-92f8-f86279de696f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVacuum Bag
Version Model NumberVB1007035
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 Usefalse
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
GS100815212021121 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-13

On-Brand Devices [Vacuum Bag]

00815212023002VB1508055
00815212021329VB1045320NV
00815212021312VB1007030NV
00815212021305VB707020B
00815212021299VB707020
00815212021282VB507015B
00815212021275VB507015
00815212021268VB2550225B
00815212021251VB2550225
00815212021244VB20251B
00815212021237VB20251
00815212021220VB200100120B
00815212021213VB200100120
00815212021206VB1507560B
00815212021190VB1507560
00815212021183VB15010075B
00815212021176VB15010075
00815212021169VB1045320
00815212021152VB1007040B
00815212021145VB1007040
00815212021138VB1007035B
00815212021121VB1007035
00815212021114VB1007030B
00815212021107VB1007030
00815212021091VB1006021
00815212021084VB10010040B
00815212021077VB10010040

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