ARMSTRONG R VENT TUBE

GUDID 10844505012635

ARMSTRONG R VENT TUBE 1.14MM ID SILICONE 5 PACK

Grace Medical, Inc.

Tympanostomy tube

• Primary Device ID: 10844505012635
• NIH Device Record Key: 6045fea3-5971-4272-9a8e-06023c93515f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARMSTRONG R VENT TUBE
• Version Model Number: 510-311
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505012638 [Primary]
GS1	10844505012635 [Package]; Contains: 00844505012638; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981575

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: 2
• Public Version Date: 2020-04-27
• Device Publish Date: 2019-08-21

On-Brand Devices [ARMSTRONG R VENT TUBE]

• 00844505011174: ARMSTRONG R VENT TUBE W/TAB 1.14 MM ID SILICONE 30 PACK
• 00844505008488: ARMSTRONG R VENT TUBE 1.14MM ID - BLUE FLUOROPLASTIC PAIR 60 PACK
• 00844505008471: ARMSTRONG R VENT TUBE 1.14 MM ID - BLUE FLUOROPLASTIC 30 PACK
• 00844505008464: ARMSTRONG R VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC PAIR 10 PACK
• 00844505008334: ARMSTRONG R VENT TUBE 1.14 MM ID - FLUOROPLASTIC PLASTIC PAIR 60 PACK
• 00844505008303: ARMSTRONG R VENT TUBE 1.14 MM ID - FLUOROPLASTIC 30 PACK
• 00844505008297: ARMSTRONG R VENT TUBE 1.14 MM ID FLUOROPLASTIC PAIR 10 PACK
• 00844505007917: ARMSTRONG R VENT TUBE 1.14MM ID SILICONE PAIR 10 PACK
• 00844505007900: ARMSTRONG R VENT TUBE 1.14MM ID SILICONE 5 PACK
• 00844505007856: ARMSTRONG R VENT TUBE W/TAB 1.14 MM ID SILICONE PAIR 10 PACK
• 00844505006415: ARMSTRONG R VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
• 00844505006408: ARMSTRONG R VENT TUBE W/TAB 1.14 MM ID SILICONE 5 PACK
• 00844505004015: ARMSTRONG R VENT TUBE 1.14 MM ID FLUOROPLASTIC 5 PACK
• 10844505012635: ARMSTRONG R VENT TUBE 1.14MM ID SILICONE 5 PACK