SOLOS

GUDID 00862311000465

5mm Right Angle Suction Coagulator

SOLOS ENDOSCOPY, INC.

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00862311000465
• NIH Device Record Key: 1ed6766f-e29d-42d7-b2f0-3345ac647c81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLOS
• Version Model Number: GS5250
• Company DUNS: 625281332
• Company Name: SOLOS ENDOSCOPY, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00862311000465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925114

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00862311000465]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-21
• Device Publish Date: 2017-05-26

On-Brand Devices [SOLOS]

• 00866370000398: Grasping FRCP, 5mm, Dolphin Nose
• 00866370000381: Curved Dissector, 5mm, Monopolar
• 00866370000374: Right Angle Dissector, 90 degree
• 00866370000367: Glassman Type Clamp, 40mm jaw
• 00866370000350: Hook Suction Coagulator
• 00866370000343: Spatula Suction Coagulator, 5mm
• 00866370000336: Right Angled Dissector, 10mm
• 00866370000329: Glassman Clamp, 5mm, 40mm jaw
• 00866370000312: Glassman Clamp, 5mm, 20mm jaw,
• 00866370000305: Curved Dissector, 5mm, Rotatable
• 00862311000496: 10mm Glassman Forcep, Ratcheting Handle
• 00862311000489: 5mm Grasping Forcep, Monopolar Handle w/Rotation
• 00862311000472: 5mm Mixture Dissector, Monopolar Handle w/Rotation
• 00862311000465: 5mm Right Angle Suction Coagulator
• 00862311000458: 5mm Micro Dissecting Forcep, Monopolar Handle
• 00862311000441: 5mm Allis Forcep, Ratcheting Handle
• 00862311000434: 10mm Spoon Forcep, Auto Closure Handle
• 00862311000427: 10mm Claw Forcep, Auto Closure Handle
• 00862311000410: 5mm Grasping Forcep, Monopolar Handle
• 00862311000403: 5mm Grasping Forcep, Ratcheting Handle
• 00841019112090: Reusable Monopolar Endoscopic Cord 10ft. (3m)
• 10841019112080: Disposable Monopolar Endoscopic Cord 10FT. (3M)