Apyx BVX-270BPP

GUDID 00607151012441

RENUVION PRECISE Blade Tip, 5mm-Ø, 27cm-length, Pistol Grip

APYX MEDICAL CORPORATION

Electrosurgical system Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use

• Primary Device ID: 00607151012441
• NIH Device Record Key: 4dccbf5e-2cbe-4d23-a8dd-c010717de09b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apyx
• Version Model Number: BVX-270BPP
• Catalog Number: BVX-270BPP
• Company DUNS: 101223287
• Company Name: APYX MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: 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
GS1	00607151012441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183610

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-16
• Device Publish Date: 2019-06-27

Devices Manufactured by APYX MEDICAL CORPORATION

• 00607151050238 - Renuvion®: 2023-06-28 RENUVION® MICRO HANDPIECE (10 cm)
• 00607151050245 - Apyx®: 2023-05-01
• 00607151050177 - J-Plasma®: 2023-04-04 J-Plasma Precise® FLEX
• 00607151050221 - Apyx®: 2023-04-04 Apyx One Console
• 00607151050184 - Renuvion®: 2022-07-11 Renuvion® Dermal Handpiece 44mm
• 00607151050214 - Renuvion®: 2022-07-11 Renuvion® Spacer, Derm
• 00607151049973 - Apyx®: 2021-05-21 Disposable Split Adult Return Electrode with Cable
• 00607151050009 - Renuvion®/J-Plasma®: 2020-03-31 Renuvion®/J-Plasma Precise® Blade Tip, 5mm-Ø, 150mm-Length, Pistol Grip