SCOPE, CABOT LAPAROCATOR

GUDID 00821925000186

Gyrus Acmi, Inc.

Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope Rigid endoscope telescope
Primary Device ID00821925000186
NIH Device Record Key41dcda1c-e459-4d80-b219-27d890bff8f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCOPE, CABOT LAPAROCATOR
Version Model Number002399-501
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 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
GS100821925000186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNHLaparoscopic contraceptive tubal occlusion device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


[00821925000186]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-08

Devices Manufactured by Gyrus Acmi, Inc.

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00821925041400 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR
00821925041417 - InstaClear2024-04-30 SHEATH LENS CLEANER ULTRA 30DEG, BOTTOM LIGHT INSTACLEAR
00821925041424 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR
00821925041431 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
00821925041448 - InstaClear2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR
00821925041455 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR

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