VACURETTE "F" TIP 6MM 10/PKG

GUDID 00821925004603

Gyrus Acmi, Inc.

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Primary Device ID00821925004603
NIH Device Record Keydc6896ea-1889-4f6b-8061-779f2bd51e15
Commercial Distribution StatusIn Commercial Distribution
Brand NameVACURETTE "F" TIP 6MM 10/PKG
Version Model Number21665
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count1
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 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
GS100821925004603 [Package]
Contains: 00821925037618
Package: [10 Units]
In Commercial Distribution
GS100821925037618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHISYSTEM, ABORTION, VACUUM
HHKCurette, Suction, Endometrial (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-11

Devices Manufactured by Gyrus Acmi, Inc.

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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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