Gynex

GUDID GYNX1412180

GYNEX CORPORATION

Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode

• Primary Device ID: GYNX1412180
• NIH Device Record Key: dde62526-61a3-4008-b720-2a1cdc9df6eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gynex
• Version Model Number: 14-1218
• Company DUNS: 012997685
• Company Name: GYNEX CORPORATION
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	GYNX1412180 [Unit of Use]
HIBCC	GYNX1412181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982739

FDA Product Code

• HGI: Electrocautery, Gynecologic (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-07
• Device Publish Date: 2023-06-29

On-Brand Devices [Gynex]

• GYNX10050: 1005
• GYNX12400: 1240
• GYNX12350: 1235
• GYNX12300: 1230
• GYNX12250: 1225
• GYNX12200: 1220
• GYNX12150: 1215
• GYNX12100: 1210
• GYNX12050: 1205
• GYNX1200400: 1200-40
• GYNX1200350: 1200-35
• GYNX1200300: 1200-30
• GYNX1200250: 1200-25
• GYNX1200200: 1200-20
• GYNX1200150: 1200-15
• GYNX1200100: 1200-10
• GYNX1200050: 1200-05
• GYNX12000: 1200
• GYNX10750: 1075
• GYNX10700: 1070
• GYNX10650: 1065
• GYNX10600: 1060
• GYNX10530: 1053
• GYNX10500: 1050
• GYNX10450: 1045
• GYNX10390: 1039
• GYNX10370: 1037
• GYNX10350: 1035
• GYNX10330: 1033
• GYNX10300: 1030
• GYNX10290: 1029
• GYNX10270: 1027
• GYNX10260: 1026
• GYNX10250: 1025
• GYNX10220: 1022
• GYNX10210: 1021
• GYNX102001: 10-200
• GYNX10200: 1020
• GYNX10190: 1019
• GYNX10170: 1017
• GYNX10150: 1015
• GYNX10140: 1014
• GYNX10120: 1012
• GYNX10100: 1010
• GYNX10080: 1008
• GYNX10070: 1007
• GYNX10060: 1006
• GYNX25400: 2540
• GYNX25300: 2530
• GYNX25250: 2525