ApollOS

GUDID 00844505014403

ApollOS™

Grace Medical, Inc.

Mouthguard, single-use

• Primary Device ID: 00844505014403
• NIH Device Record Key: 90746a90-b4c8-4d3e-98b6-0734053c4ae6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApollOS
• Version Model Number: 800
• Company DUNS: 030849173
• Company Name: Grace Medical, 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505014403 [Primary]
GS1	10844505014400 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• LRC: Instrument, Ent Manual Surgical

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: 2024-05-13
• Device Publish Date: 2024-05-03

Devices Manufactured by Grace Medical, Inc.

• 00844505014335 - CUEVA DISSECTOR: 2024-11-25 CUEVA NO.1 DISSECTOR, DOUBLE-ENDED, STAINLESS STEEL
• 00844505014403 - ApollOS: 2024-05-13ApollOS™
• 00844505014403 - ApollOS: 2024-05-13 ApollOS™
• 10844505014394 - TOUMA VENT TUBE W/ TAB: 2024-01-31 MODIFIED TOUMA VENT TUBE W/ TAB 1.27MM ID SILICONE
• 10844505014004 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 5 PACK
• 10844505014042 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
• 10844505014080 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 10 PACK
• 10108445050141 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 10 PACK
• 10844505014165 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 30 PACK