Precision Spine

GUDID 00841019109519

Bipolar Coagulation Forceps 8" (20.3cm) Working Length Cushing Bayonet Insulated, 1mm Tip

Precision Spine

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00841019109519
• NIH Device Record Key: fe5f1bc2-16f3-4258-a52e-2f2da63e3b80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Spine
• Version Model Number: 54-BP-1000
• Company DUNS: 151352023
• Company Name: Precision Spine
• 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: true
• 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

Customer Support Contacts

• Phone: 781-834-9500
• Email: kprario@ksp.com

Device Dimensions

• Length: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019109519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811820

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00841019109519]

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: 2016-07-10

On-Brand Devices [Precision Spine]

• 20841019109520: Bipolar Coagulation Forceps 8" (20.3cm) Working Length Hardy Bayonet Insulated, 1mm Tip
• 00841019109519: Bipolar Coagulation Forceps 8" (20.3cm) Working Length Cushing Bayonet Insulated, 1mm Tip