003853-902 BERKELEY SAFETOUCH Tissue Trap

GUDID 00821925000032

Gyrus Acmi, Inc.

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Primary Device ID00821925000032
NIH Device Record Key106ee69e-e145-4b7f-95cd-0970694af7f1
Commercial Distribution StatusIn Commercial Distribution
Brand Name003853-902 BERKELEY SAFETOUCH Tissue Trap
Version Model Number003853-902
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 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
GS100821925000032 [Package]
Contains: 00821925037861
Package: [10 Units]
In Commercial Distribution
GS100821925037861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHISYSTEM, ABORTION, VACUUM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

Devices Manufactured by Gyrus Acmi, Inc.

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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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