CLEANING KIT NONSTERILE FOR DRILL, ATTACHMENTS Diego Elite Drill

GUDID 00821925035829

Gyrus Acmi, Inc.

Surgical instrument/endoscope cleaning brush/tool, reusable
Primary Device ID00821925035829
NIH Device Record Keyc7667ae4-102d-4abb-ab8d-b579c0d0ec26
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEANING KIT NONSTERILE FOR DRILL, ATTACHMENTS Diego Elite Drill
Version Model NumberHSDCK200
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 Usetrue
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
GS100821925035829 [Package]
Contains: 00821925035843
Package: [5 Units]
In Commercial Distribution
GS100821925035843 [Primary]

FDA Product Code

LRCINSTRUMENT, ENT MANUAL SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2018-09-13

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