Gynex

GUDID GYNXLE0220

GYNEX CORPORATION

Vaginal speculum, reusable

• Primary Device ID: GYNXLE0220
• NIH Device Record Key: bb090943-e396-495a-9f65-c546a2b863f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gynex
• Version Model Number: LE022
• Company DUNS: 012997685
• Company Name: GYNEX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	GYNXLE0220 [Primary]

FDA Product Code

• HDF: Speculum, Vaginal, Metal

Sterilization

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

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

[GYNXLE0220]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-28
• Device Publish Date: 2023-12-20

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