RONIN

GUDID 00850061395016

HEADLAMP, OPERATING, BATTERY-OPERATED

Ronin Surgical Corp.

Head-worn lamp

• Primary Device ID: 00850061395016
• NIH Device Record Key: e94beab5-a72e-4076-94ad-ddda162e67a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RONIN
• Version Model Number: X7
• Company DUNS: 059816500
• Company Name: Ronin Surgical Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850061395016 [Primary]

FDA Product Code

• HPP: Headlamp, Operating, Battery-Operated

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-16
• Device Publish Date: 2025-06-06

On-Brand Devices [RONIN]

• 00850061395009: HEADLAMP, OPERATING, BATTERY-OPERATED
• 00850061395016: HEADLAMP, OPERATING, BATTERY-OPERATED