Mediflex Laparoscopic Instruments - Reusable Electrodes 92501

GUDID 00842102104909

J Hook Cautery, 3.5mm x 26cm

FLEXBAR MACHINE CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 00842102104909
• NIH Device Record Key: 32b7ab12-343e-48fa-aa5b-8d9b4174fa29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediflex Laparoscopic Instruments - Reusable Electrodes
• Version Model Number: 92501
• Catalog Number: 92501
• Company DUNS: 047644935
• Company Name: FLEXBAR MACHINE 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: false
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	00842102104909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103840

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00842102104909]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [Mediflex Laparoscopic Instruments - Reusable Electrodes]

• 00842102105005: J-Hook Electrode, 5mm x 45cm
• 00842102104992: L-Hook Electrode, 5mm x 45cm
• 00842102104985: Spatula Tip Electrode, 5mm x 45cm
• 00842102104978: J-Hook Electrode, 5mm x 33cm
• 00842102104961: L-Hook Electrode, 5mm x 33cm
• 00842102104954: Spatula Tip Electrode, 5mm x 33cm
• 00842102104947: Spatula Cautery 3.5mm x 33cm
• 00842102104930: J Hook Cautery 3.5mm x 33cm
• 00842102104923: L Hook Cautery 3.5mm x 33cm
• 00842102104916: Spatula Cautery, 3.5mm x 26cm
• 00842102104909: J Hook Cautery, 3.5mm x 26cm
• 00842102104893: L Hook Cautery, 3.5mm x 26cm