Endo-diathermy handle, straight pointed tip.(27 gauge / 0.4 mm) 1120.04

GUDID 08717872016900

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Primary Device ID08717872016900
NIH Device Record Keyc86c8ca3-76e0-47cf-85d8-03abe4296e39
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo-diathermy handle, straight pointed tip.(27 gauge / 0.4 mm)
Version Model Number1120.04
Catalog Number1120.04
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
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
GS108717872016900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQRApparatus, Cautery, Radiofrequency, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717872016900]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-17
Device Publish Date2016-09-24

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