Jac-cell USA

GUDID B461JAU142011

Disposable PTFE Coated Blade Electrode - Shrink Wrap Insulated, ETO Sterile

JAC CELL USA INC

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

• Primary Device ID: B461JAU142011
• NIH Device Record Key: b54fff81-9743-414e-9e97-c04d8432cdd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jac-cell USA
• Version Model Number: JAU-1420
• Company DUNS: 015023538
• Company Name: JAC CELL USA INC
• Device Count: 10
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B461JAU14201 [Unit of Use]
HIBCC	B461JAU142011 [Primary]

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: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-08-30

On-Brand Devices [Jac-cell USA]

• B461JAU142011: Disposable PTFE Coated Blade Electrode - Shrink Wrap Insulated, ETO Sterile
• B461JAU142000: Disposable PTFE Coated Blade Electrode - Shrink Wrap Insulated, ETO Sterile