Kelly Keyhole Organization Tray 1

GUDID 00810009461692

Trays

MIZUHO AMERICA, INC.

Instrument tray, reusable
Primary Device ID00810009461692
NIH Device Record Keyf0cf74b1-44c0-4939-8cfb-807a3ef4fa97
Commercial Distribution StatusIn Commercial Distribution
Brand NameKelly Keyhole Organization Tray 1
Version Model Number07-822-00MA
Company DUNS877624940
Company NameMIZUHO AMERICA, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810009461692 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


[00810009461692]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-13
Device Publish Date2022-12-05

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00810009460541 - Yasargil Tumor Forceps, Bayonet, 5mm Serrated Spoon, 9cm WL2023-08-23 Actuated Holder
00810009460824 - Yasargil Forceps, Bayonet, 11.5cm WL2023-08-23 Actuated Holder
00810009461180 - Ring Curette, Donut Style, 3mm, 125 Degrees Up, 15cm WL2023-08-23 Static Instrument
00810009462132 - Sizer Dissector, Straight2023-08-23 Static Instrumanet
00810009463054 - Rotatable Biopsy Forceps, 2mm Spoon, 12cm WL2023-08-23 Actuated Holder

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