Basic, Quick-Release Head Immobilizer

GUDID 00616784562926

Basic, Quick-Release Head Immobilizer, White

DYNAREX CORPORATION

Head/neck immobilizer, single-use
Primary Device ID00616784562926
NIH Device Record Keycda954a4-7a54-4a9f-a66c-f89847c53544
Commercial Distribution StatusIn Commercial Distribution
Brand NameBasic, Quick-Release Head Immobilizer
Version Model Number5629
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784562926 [Unit of Use]
GS100616784562933 [Primary]

FDA Product Code

MRIOrthosis, Truncal/Orthosis, Limb

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-09
Device Publish Date2021-09-01

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