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.

• 00844505014694 - SKULL BASE: 2025-10-06 SKULL BASE ROUND KNIFE ANGLED 45° STAINLESS STEEL
• 00844505014700 - SKULL BASE: 2025-10-06 RIGHT ANGLE SIZING ROD STAINLESS STEEL
• 00844505014717 - SKULL BASE: 2025-10-06 DOUBLE-ENDED DISSECTOR STRAIGHT CUEVA AND SPOON STAINLESS STEEL
• 00844505014724 - SKULL BASE: 2025-10-06 EXTENDED THOMASSIN DISSECTOR DOUBLE-ENDED STAINLESS STEEL
• 00844505014502 - TITANIUM PISTON: 2025-09-26 TITANIUM PISTON 0.6MM DIA X 5.75MM L TITANIUM/RIBBON
• 00844505014687 - GRACE MEDICAL FLUOROPLASTIC PISTON: 2025-09-26 FLUOROPLASTIC PISTON 0.6MM DIA X 5.50MM L
• 00844505014489 - ECLIPSE PISTON: 2025-08-13 ECLIPSE PISTON 0.5MM DIA X 3.50MM L NITINOL/FLUOROPLASTIC
• 00844505014519 - TITANIUM PISTON: 2025-08-13 TITANIUM PISTON 0.4MM DIA X 5.75MM L TITANIUM/RIBBON