Serene Medical

GUDID B653PB100T0

SERENE MEDICAL, INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: B653PB100T0
• NIH Device Record Key: 283c2110-81ee-461a-b9c3-33ef6c2e5cbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serene Medical
• Version Model Number: PB-100T
• Company DUNS: 045060651
• Company Name: SERENE MEDICAL, INC.
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B653PB100T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081729

FDA Product Code

• GXD: Generator, Lesion, Radiofrequency

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-12-01

On-Brand Devices [Serene Medical]

• B653RFG100TC0: RFG-100.TC
• B653PB100T0: PB-100T