Spatula for Bovie Pencil Handle OS-SPAT-33-5-B

GUDID B354OSSPAT335B10

Spatula for Bovie Pencil Handle

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354OSSPAT335B10
• NIH Device Record Key: ebd5c924-af9f-4361-87cb-6d5e0b8a9908
• Commercial Distribution Discontinuation: 2019-11-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Spatula for Bovie Pencil Handle
• Version Model Number: OS-SPAT-33-5-B
• Catalog Number: OS-SPAT-33-5-B
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B354OSSPAT335B0 [Primary]
HIBCC	B354OSSPAT335B10 [Package]; Contains: B354OSSPAT335B0; Package: [10 Units]; Discontinued: 2019-11-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

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: 3
• Public Version Date: 2019-11-14
• Device Publish Date: 2016-11-14

On-Brand Devices [ Spatula for Bovie Pencil Handle]

• B354OSSPAT445B10: Spatula for Bovie Pencil Handle
• B354OSSPAT335B10: Spatula for Bovie Pencil Handle