Grace Medical, Inc.

GUDID 10850038863194

OTOMED® SUCTION TUBING

Directmed, Inc.

Surgical irrigation tubing set, single-use

• Primary Device ID: 10850038863194
• NIH Device Record Key: 01623c04-2db8-4235-8bf8-108b86f11bfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grace Medical, Inc.
• Version Model Number: SP-4000
• Company DUNS: 969484237
• Company Name: Directmed, Inc.
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850038863194 [Primary]

FDA Product Code

• GBX: Catheter, Irrigation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-26
• Device Publish Date: 2024-11-18

On-Brand Devices [Grace Medical, Inc.]

• 00850038863197: OTOMED® SUCTION TUBING
• 00850038863180: LEVINE IRRIGATION – SUCTION TUBING
• 10850038863194: OTOMED® SUCTION TUBING
• 10850038863187: LEVINE IRRIGATION – SUCTION TUBING