8191-02

GUDID 20845854038861

3DHD SINGLE CHANNEL STEREO ENDOSCOPE 10MM 30 DEGREE

Conmed Corporation

Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator Ear lobe perforator
Primary Device ID20845854038861
NIH Device Record Key7e8506aa-5e93-40ee-8cb8-9f1735c2f1a7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8191-02
Catalog Number8191-02
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 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

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 Identifiers

Device Issuing AgencyDevice ID
GS100845854038867 [Primary]
GS120845854038861 [Direct Marking]

FDA Product Code

FETEndoscopic video imaging system/component, gastroenterology-urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

[20845854038861]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by Conmed Corporation

30845854026797 - GENESYS CrossFT, Hi-Fi2024-04-25 5.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures
30845854026803 - GENESYS CrossFT, Hi-Fi2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Two #2 (5 metric) Hi-Fi Sutures
30845854026810 - GENESYS CrossFT, Hi-Fi2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures
30845854027862 - GENESYS PressFT, Hi-Fi2024-04-25 GENESYS PressFT 2.1 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
30845854027893 - GENESYS PressFT, Hi-Fi2024-04-25 GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
30845854034600 - GENESYS CrossFT, Hi-Fi2024-04-25 GENESYS CrossFT 5.5 mm Suture Anchor, w/3 Hi-Fi #2 (5 metric) Sutures w/Needles
30845854034617 - GENESYS CrossFT, Hi-Fi2024-04-25 GENESYS CrossFT 6.5 mm Suture Anchor, w/2 Hi-Fi #2 (5 metric) Sutures w/Needles
30653405988643 - Argo Knotless GENESYS2024-04-22 5.5mm Argo Knotless® GENESYSTM Anchor
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