DETACHAPORT 1-7057

GUDID 40653405037096

DETACHAPORT 12MM OPEN ENTRY WEDGE, MULTIPLE USE OPEN ENTRY TROCAR WEDGE

Conmed Corporation

Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable Laparoscopic access cannula, reusable
Primary Device ID40653405037096
NIH Device Record Key2701a25e-93e6-4be8-85d8-3be590c9d4ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameDETACHAPORT
Version Model Number1-7057
Catalog Number1-7057
Company DUNS071595540
Company NameConmed Corporation
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

Customer Support Contacts

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS130653405037099 [Primary]
GS140653405037096 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


[40653405037096]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [DETACHAPORT]

40653405039045DETACHAPORT OBTURATOR AND SEAL SET, (10) 12MM X 100MM OBTURATOR, (20) 5MM, 10/12MM CONVERTER
40653405039014DETACHAPORT OBTURATOR AND SEAL SET, (10) 10MM X 100MM OBTURATOR, (10) 5MM, 10/12MM CONVERTER
30653405038171LAP CHOLE KIT, DETACHAPORT
40653405037096DETACHAPORT 12MM OPEN ENTRY WEDGE, MULTIPLE USE OPEN ENTRY TROCAR WEDGE
40653405037089DETACHAPORT 12MM X 150MM, MULTI-USE OPEN ENTRY OBTURATOR
40653405037072DETACHAPORT 12MM X 100MM OPEN ENTRY OBTURATOR, MULTI-USE OPEN ENTRY OBTURATOR
40653405037065DETACHAPORT OPEN ENTRY WEDGE SILICONE REPLACEMENT SEAL
20653405037054DETACHAPORT UNIVERSAL CONVERTER, 5MM, 10/12MM CONVERTER
20653405037047DETACHAPORT SEAL WITH REDUCER, 10/12MM SEAL SET
40653405037034DETACHAPORT PORT SAVER, TROCAR GHOST STICK
20653405036682DETACHAPORT OBTURATOR AND SEAL SET, (1) 5MM X 100MM OBTURATOR, (1) 5MM SEAL SET
20653405036675DETACHAPORT OBTURATOR AND SEAL SET, (1) 5MM X 70MM OBTURATOR, (2) 5MM SEAL SETS
20653405036668DETACHAPORT (1)5mmx70mm Obturator & (1)5mm Seal Set
20653405036651DETACHAPORT 5mm Seal Set (Includes 1 Stopcock)
40653405036648DETACHAPORT Multiple Use Threaded Titanium Cannula, 12mmx150mm
40653405036631DETACHAPORT Multiple Use Threaded Titanium Cannula, 12mmx100mm
20653405036545DETACHAPORT OBTURATOR AND SEAL SET, (1) 5MM X 100MM OBTURATOR, (2) 5MM SEAL SETS
20653405036521DETACHAPORT OBTURATOR AND SEAL SET WITH REDUCER, (1) 12MM X 150MM OBTURATOR, (1) 10/12MM SEAL SE
20653405036514DETACHAPORT OBTURATOR AND SEAL SET WITH REDUCERS, (1) 12MM X 100MM OBTURATOR, (2) 10/12MM SEAL S
20653405036507DETACHAPORT OBTURATOR AND SEAL SET WITH REDUCER, (1) 12MM X 100MM OBTURATOR, (1) 10/12MM SEAL SE
20653405036491DETACHAPORT OBTURATOR AND SEAL SET WITH REDUCERS, (1) 10MM X 100MM OBTURATOR, (2) 10/12MM SEAL S
20653405036484DETACHAPORT OBTURATOR AND SEAL SET WITH REDUCER, (1) 10MM X 100MM OBTURATOR, (1) 10/12MM SEAL SE
00653405036626DETACHAPORT Multiple Use Threaded Titanium Cannula, 10mmx100mm
00653405036619DETACHAPORT Multiple Use Threaded Titanium Cannula, 5mmx100mm
00653405036602DETACHAPORT Multiple Use Threaded Titanium Cannula, 5mmx70mm
00653405036596DETACHAPORT Multiple Use Titanium Cannula, 12mmx150mm
00653405036589DETACHAPORT Multiple Use Titanium Cannula, 12mmx100mm
00653405036572DETACHAPORT Multiple Use Titanium Cannula, 10mmx100mm
00653405036565DETACHAPORT Multiple Use Titanium Cannula, 5mmx100mm
00653405036558DETACHAPORT Multiple Use Titanium Cannula, 5mmx70mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.