Cathay

GUDID 06959006300499

ADULT USE, BLUE GEL, BIPOAR

CATHAY MANUFACTURING CORP.

Electrosurgical return electrode, single-use

• Primary Device ID: 06959006300499
• NIH Device Record Key: 9f0320e8-5c71-46f4-b329-015dc71dd411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cathay
• Version Model Number: GP202S-TB
• Company DUNS: 421287342
• Company Name: CATHAY MANUFACTURING CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06959006300499 [Primary]
GS1	16959006300496 [Package]; Package: box [25 Units]; In Commercial Distribution
GS1	26959006300493 [Package]; Contains: 16959006300496; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130027

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-16
• Device Publish Date: 2023-10-08

On-Brand Devices [Cathay]

• 06959006302837: Tens electrode
• 06959006302783: Tens electrode
• 06959006302752: Tens electrode
• 06959006302646: Tens electrode
• 06959006302332: Tens electrode
• 06959006302226: Tens electrodes
• 06959006302172: Tens electrode
• 06959006302073: Tens electrode
• 06959006302066: Tens electrode
• 06959006300680: GP202D-AC
• 06959006300673: GP202S-AC
• 06959006300222: GP202D-A
• 06959006300208: GP202S-A
• 16959006303268: Monopolar Adult Grounding Pad with Cable
• 16959006300397: Horizontal Monopolar Adult Grounding Pad
• 16959006303299: Bipolar Adult Grounding Pad with Cable
• 16959006303589: TENs Electrodes
• 16959006303541: TENs Electrodes
• 16959006304418: Disposable Neutral Electrode, adult use, monopolar, pre-attached with extra long cable.
• 16959006304401: Disposable neutral electrode, adult use, bipolar, pre-attached with extra long cable.
• 16959006302988: Disposable Electrosurgical Pencil, hand control
• 16959006300823: Disposable Neutral Electrode, adult use, monopolar, pre-attached 3 meters cable
• 16959006300816: Adult use, bipolar, disposable neutral electrode, pre-attached 3 meters cable
• 16959006300786: Pediatric use, monopolar, with cable; disposable neutral electrode
• 16959006300779: Pediatric use, bipolar, pre-attached with cable
• 16959006300502: Adult use, blue gel, monopolar, disposable neutral electrode
• 06959006300499: ADULT USE, BLUE GEL, BIPOAR