ARMSTRONG X VENT TUBE

GUDID 00844505008495

ARMSTRONG X BEVELED GROMMET 1.14MM ID BLUE FLUOROPLASTIC 5 PACK

Grace Medical, Inc.

Tympanostomy tube

• Primary Device ID: 00844505008495
• NIH Device Record Key: 0fc56ed7-ca68-4559-8643-1b6b7be7072f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARMSTRONG X VENT TUBE
• Version Model Number: 525-201
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505008495 [Primary]
GS1	10844505008492 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062385

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-14
• Device Publish Date: 2016-02-18

On-Brand Devices [ARMSTRONG X VENT TUBE]

• 00844505008501: ARMSTRONG X BEVELED GROMMET 1.14MM ID BLUE FLUOROPLASTIC 30 PACK
• 00844505008495: ARMSTRONG X BEVELED GROMMET 1.14MM ID BLUE FLUOROPLASTIC 5 PACK