BUCK WAX CURETTE DISPOSABLE SIZE 3

GUDID 00821925017795

Gyrus Acmi, Inc.

General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette General-purpose curette
Primary Device ID00821925017795
NIH Device Record Key2b3865ae-4863-4a84-9345-2d33f1ca47a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBUCK WAX CURETTE DISPOSABLE SIZE 3
Version Model Number130762
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925017795 [Package]
Contains: 00821925033399
Package: [6 Units]
In Commercial Distribution
GS100821925033399 [Primary]

FDA Product Code

LRCINSTRUMENT, ENT MANUAL SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-10
Device Publish Date2018-09-10

Devices Manufactured by Gyrus Acmi, Inc.

00810008180983 - nCare2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
00810008180990 - nCare2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
00810008180501 - nCare2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
00810008180921 - nCare2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
00810008180952 - nCare2023-09-25 nCare, SNGL,DRCT SDI,DICOM
00810008180969 - nCare2023-09-25 nCare, SNGL, ELA, DICOM
00810008180976 - nCare2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
00821925036406 - USA Elite2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)

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