J Hook non-stick with cable OS-J-Hook-33-5-C

GUDID B354OSJHOOK335C10

J Hook non-stick with cable

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354OSJHOOK335C10
• NIH Device Record Key: a27abe88-841a-4315-b63c-e6af5cc188ba
• Commercial Distribution Discontinuation: 2019-11-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: J Hook non-stick with cable
• Version Model Number: OS-J-Hook-33-5-C
• Catalog Number: OS-J-Hook-33-5-C
• 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	B354OSJHOOK335C0 [Primary]
HIBCC	B354OSJHOOK335C10 [Package]; Contains: B354OSJHOOK335C0; 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 [J Hook non-stick with cable]

• B354OSJHOOK445C10: J Hook non-stick with cable
• B354OSJHOOK335C10: J Hook non-stick with cable