EAR SURGERY SPECULUM 3.0 MM EBONY FINISH

GUDID 00821925014756

Gyrus Acmi, Inc.

Cotton pledget applicator, single-use
Primary Device ID00821925014756
NIH Device Record Keya8ade0ad-babe-4544-88d5-b03c574a325b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEAR SURGERY SPECULUM 3.0 MM EBONY FINISH
Version Model Number130630
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925014756 [Primary]

FDA Product Code

EPYSpeculum, Ent
KCJAPPLICATOR, ENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


[00821925014756]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-07
Device Publish Date2018-09-10

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