PKS OMNI 5mm/24cm

GUDID 00821925011304

Gyrus Acmi, Inc.

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID00821925011304
NIH Device Record Key161d88f0-06d9-440e-9482-316bbd549942
Commercial Distribution StatusIn Commercial Distribution
Brand NamePKS OMNI 5mm/24cm
Version Model Number970005PC
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
GS100821925011304 [Package]
Contains: 00821925036321
Package: [5 Units]
In Commercial Distribution
GS100821925036321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-10-04

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00821925041431 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
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