Bovie

GUDID 00887482179253

Electrosurgical Rocker Pencil 50/Bx

SYMMETRY SURGICAL INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00887482179253
• NIH Device Record Key: 3be3b8cf-1dd5-4491-9fd9-022b1c3eb3a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bovie
• Version Model Number: ESP6
• Company DUNS: 079641356
• Company Name: SYMMETRY SURGICAL 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887482179253 [Package]; Contains: 10887482179243; Package: [50 Units]; In Commercial Distribution
GS1	10887482179243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K936304

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-05
• Device Publish Date: 2024-08-28

On-Brand Devices [Bovie]

• 00887482179871: Laparoscopic L-Hook (Heavy) Elect w/ 4mm(.157") Adapter (5/bx)
• 00887482179857: Laparoscopic Curved Blade Electrode With 4mm(.157")Adapt (5/bx)
• 00887482179833: Laparoscopic Ball Electrode With 4mm (.157") Adapter
• 00887482180747: Deluxe Change A Tip; Hi-Lo Temp Cautery Kit
• 00887482180730: Change-A-Tip Deluxe High
• 00887482180723: Change-A-Tip Deluxe Low
• 00887482179970: Laparoscopic Spatula Electrode With 4mm (.157") Adapter (5/bx)
• 00887482179956: Laparoscopic Needle Electrode With 4mm (.157") Adapter (5/bx)
• 00887482179932: Laparoscopic Std Blade Electr With 4mm(.157") Adapter (5/bx)
• 00887482179918: Laparoscopic J-Hook (Wire) Elect w/ 4mm (.157") Adapter
• 00887482179895: Laparoscopic L-Hook (Wire) Elect w/ 4mm(.157") Adapter (5/bx)
• 10887482181529: Monopolar Footswitch Bovie
• 10887482181512: Bipolar Footswitch Bovie
• 00887482181492: Bovie® Arthroscopy Electrode Hook 90° (5/bx)
• 00887482177655: Bovie® Arthroscopy Electrode Meniscectomy (5/bx)
• 00887482177631: Bovie® Arthroscopy Electrode Acromioplasty (5/bx)
• 00887482177617: Bovie® Arthroscopy Electrode Hook 45° (5/bx)
• 00887482176825: Eye Bubble (10/bx)
• 00887482182550: Electrosurgical Generator + High Frequency Desiccator
• 00887482182536: High Frequency Desiccator Monopolar/ Bipolar
• 00887482181508: Bovie High Frequency Electrosurgical Generator
• 00887482181324: Bovie High Frequency Electrosurgical Generator
• 00887482177020: Grounding Plate w/ Cord (for use with A800-EU, A900, A940, A942, DERM 101, DERM 102)
• 00887482176993: Dispersive Electrode Cable For Reusable Plate 1250/2100
• 00887482176986: Reusable Grounding Cable
• 00887482176948: Grounding Plate A1200
• 00887482176931: Reusable Cord For Reusable Grounding Plate
• 00887482176924: Grounding Plate With Cord
• 00887482176894: Reusable Cable Grounding Pad
• 00887482149690: Bipolar Forceps Mcpherson Curved 3.5" w/.5mm Tip-Un Coat
• 00887482149683: Bipolar Forceps Tenzel 4" w/.5mm Tip-Un Coated
• 00887482149676: Bipolar Forceps Mcpherson Straight 3.5 w/.5mm Tip-Coated
• 00887482149669: Bipolar Forceps Mcpherson Curved 3.5" w/.5mm Tip-Coated
• 00887482149652: Bipolar Forceps 4" Tenzel w/.5mm Tip-Coated
• 00887482149645: Bipolar Forceps 4.5" Straight Micro Tip
• 00887482149638: Bipolar Forceps 4.75" Straight Medium Tip
• 00887482149621: Bipolar Forceps 4.5" Curved Micro Tip
• 00887482149614: Bipolar Forceps 7" Curved Fine Tip
• 00887482149607: Bipolar Forceps 7" Straight Fine Tip
• 00887482149591: Bipolar Forceps 8" Bayonet 2mm Tip
• 00887482149584: Bipolar Forceps 7.25" Fine Tip
• 00887482032732: Autoclavable 3 Button Pencil
• 00887482032725: Handpiece; Autoclavable 3-Button Power Control
• 00887482181546: Electrosurgical Loop Kit (5/bx)
• 00887482179093: Super Cut Modified Fine Needle 4.5cm (5/bx)
• 00887482179079: Supercut Fine Needle Electrode 4.5cm (5/bx)
• 00887482179055: Super Cut Modified Fine Needle Electrode With Heatshrink (5/bx)
• 00887482179031: Super Cut Modified Fine Needle 3cm (5/bx)
• 00887482179017: Supercut Fine Needle Electrode 3cm (5/bx)
• 00887482178997: Resistick II Coated Mod Blade Electrode 2.5" (6.35cm) 12/ Bx