Endocervical Speculum, Ratchet Handle

GUDID GYNX21400

GYNEX CORPORATION

Manual expandable cervical dilator

• Primary Device ID: GYNX21400
• NIH Device Record Key: 91d608a7-6edc-4a3b-9dd1-6ac9fa6bdef9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endocervical Speculum, Ratchet Handle
• Version Model Number: 2140
• Company DUNS: 012997685
• Company Name: GYNEX CORPORATION
• Device Count: 1
• 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: 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	GYNX21400 [Primary]

FDA Product Code

• FXE: Speculum, Non-Illuminated

Sterilization

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

[GYNX21400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-05

On-Brand Devices [Endocervical Speculum, Ratchet Handle]

• GYNX21400: 2140
• GYNX21300: 2130