MULTIDEBRIDER HANDPIECE, ANGLED DIEGO ELITE

GUDID 00821925027749

MDHP100A MULTIDEBRIDER HANDPIECE ANGLED

Gyrus Acmi, Inc.

ENT shaver system ENT shaver system
Primary Device ID00821925027749
NIH Device Record Key85cf257b-4d50-4afd-a254-148ec956658a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMULTIDEBRIDER HANDPIECE, ANGLED DIEGO ELITE
Version Model NumberMDHP100A
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100821925027749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925027749]

Moist Heat or Steam Sterilization


[00821925027749]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-14

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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