Transducer Covers

GUDID 00616784124834

DYNAREX CORPORATION

Body-surface ultrasound imaging transducer cover
Primary Device ID00616784124834
NIH Device Record Keybf231cd1-ef48-42af-a29b-19a513116db4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransducer Covers
Version Model Number1248
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count100
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784124803 [Unit of Use]
GS100616784124810 [Primary]
GS100616784124834 [Package]
Contains: 00616784124810
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-24

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