Peng's Multifunctional Operative Dissector(Electrosurgical Pencil)

GUDID 16924274957857

Zhejiang Shuyou Surgical Instrument Co.,Ltd.

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

• Primary Device ID: 16924274957857
• NIH Device Record Key: 3fd7b619-55d2-4cf7-8753-4d9498530a43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peng's Multifunctional Operative Dissector(Electrosurgical Pencil)
• Version Model Number: 2A-D608-SG0013
• Company DUNS: 421340711
• Company Name: Zhejiang Shuyou Surgical Instrument Co.,Ltd.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06924274957850 [Primary]
GS1	16924274957857 [Package]; Contains: 06924274957850; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040780

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

[16924274957857]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-13
• Device Publish Date: 2022-05-05