ENTRIPORT G3-R12GK

GUDID 30653405082464

Fascia Anchor Adapter Seal Replacement

Conmed Corporation

Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable Laparoscopic access cannula anchor, reusable
Primary Device ID30653405082464
NIH Device Record Keya7cd9fc5-d3c1-4ec0-bc5f-8c327f188a45
Commercial Distribution StatusIn Commercial Distribution
Brand NameENTRIPORT
Version Model NumberG3-R12GK
Catalog NumberG3-R12GK
Company DUNS071595540
Company NameConmed Corporation
Device Count10
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

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405082463 [Unit of Use]
GS110653405082460 [Package]
Contains: 20653405082467
Package: POUCH [10 Units]
In Commercial Distribution
GS120653405082467 [Primary]
GS130653405082464 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

Moist Heat or Steam Sterilization


[30653405082464]

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 [ENTRIPORT]

40653405081907BLADELESS OPTICAL TROCAR
40653405081891Bladeless Mini Trocar
30653405082471Reusable Open Entry (Hassan) Obturator
30653405082464Fascia Anchor Adapter Seal Replacement
30653405082457Reusable Fascia Anchor Adapter
30653405082440Reusable Cannula
30653405082433Reusable Cannula
30653405082426Reusable Cannula
30653405082419Reusable Mini cannula
30653405082402Reusable Mini cannula
30653405082396Reusable Mini Cannula without Stopcock
10653405082385Mini seal Cap, Stopcock
10653405082378Reposable Bladeless Mini Trocar
10653405082361Reposable Bladeless Mini Trocar
10653405082354Bladeless Mini Trocar without Stopcock
10653405082347Bladed Mini Trocar without Stopcock
10653405082330Mini Cannula Sleeve
10653405082323Bladed Mini Trocar
10653405082316Reposable Bladeless Mini Trocar
10653405082309Reposable Bladed Mini Trocar
10653405082293Bladeless Mini Trocar
10653405082286Mini Cannula Sleeve
10653405082057Bladed Mini Trocar
10653405082040Seal Body, Stopcock
20653405005213Bladeless Mini Trocar
20653405081897Bladeless Mini Trocar
00653405082463Fascia Anchor Adapter Seal Replacement

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