Thermoplastic Mask

GUDID 00815212022890

Izi Medical Products, LLC

Patient positioning thermoplastic mould material
Primary Device ID00815212022890
NIH Device Record Key2082b7af-c603-4305-bfe8-d7e2b8c4fd9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermoplastic Mask
Version Model NumberMK8068
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815212022890 [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 Date2016-12-07

On-Brand Devices [Thermoplastic Mask]

00815212022906MK8069
00815212022890MK8068
00815212022746MK8067
00815212022739MK8066
00815212022722MK8201
00815212022715MK8200
00815212022708MK8101
00815212022692MK8100
00815212022685MK8064
00815212022678MK8063
00815212022661MK8062
00815212022654MK8061
00815212022647MK8060
00815212022630MK8048
00815212022623MK8047
00815212022616MK8046
00815212022609MK8045
00815212022593MK8044
00815212022586MK8043
00815212022579MK8042
00815212022562MK8041
00815212022555MK8040
00815212022548MK8039
00815212022531MK8038
00815212022524MK8037
00815212022517MK8036
00815212022500MK8035
00815212022494MK8034
00815212022487MK8032
00815212022470MK8031
00815212022463MK8030
00815212022456MK8029
00815212022449MK8028
00815212022432MK8027
00815212022425MK8026
00815212022418MK8025
00815212022401MK8024
00815212022395MK8023
00815212022388MK8021
00815212022371MK8020
00815212022364MK8019
00815212022357MK8018
00815212022340MK8017
00815212022333MK8016
00815212022326MK8015
00815212022319MK8014
00815212022302MK8013
00815212022296MK8012
00815212022289MK8011
00815212022272MK8009

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.