7FR FIXEDPIN HEMOSTATIC PROBE

GUDID 00821925039452

CD-B622LA BICOAG BIPOLAR HEMOSTASIS PROB

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use
Primary Device ID00821925039452
NIH Device Record Key7dd4b49b-f0e5-409e-834d-965939e47f3a
Commercial Distribution StatusIn Commercial Distribution
Brand Name7FR FIXEDPIN HEMOSTATIC PROBE
Version Model NumberCD-B622LA
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
GS100821925039452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNSUnit, electrosurgical, endoscopic (with or without accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-10-13

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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