OTOVIEW CUPPED FORCEPS JAWS CURVED RIGHT 45 DEGREES STAINLESS STEEL E

GUDID 00821925026285

Gyrus Acmi, Inc.

Rigid endoscopic grasping forceps, reusable Rigid endoscopic grasping forceps, reusable Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use Rigid endoscopic biopsy forceps, single-use
Primary Device ID00821925026285
NIH Device Record Keybdf4a81c-d4a1-47f9-82ef-890788c5f1b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTOVIEW CUPPED FORCEPS JAWS CURVED RIGHT 45 DEGREES STAINLESS STEEL E
Version Model Number70235611
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 Usefalse
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
GS100821925026285 [Primary]

FDA Product Code

JXXFORCEPS, WIRE CLOSURE, ENT, STERILE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


[00821925026285]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-15
Device Publish Date2018-09-12

Devices Manufactured by Gyrus Acmi, Inc.

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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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