NYTEBYTE

GUDID 00844505014649

OFFSET ALTO NYTEBYTE PARTIAL SIZERS INCLUDED TITANIUM/NITINOL/SILICONE

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505014649
• NIH Device Record Key: c145f2f2-fde3-4a93-9f71-8e7ee82aa21e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NYTEBYTE
• Version Model Number: 650N
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505014649 [Primary]

FDA Product Code

• ETB: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

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: 2025-07-10
• Device Publish Date: 2025-07-02

Devices Manufactured by Grace Medical, Inc.

• 00844505014649 - NYTEBYTE: 2025-07-10OFFSET ALTO NYTEBYTE PARTIAL SIZERS INCLUDED TITANIUM/NITINOL/SILICONE
• 00844505014649 - NYTEBYTE: 2025-07-10 OFFSET ALTO NYTEBYTE PARTIAL SIZERS INCLUDED TITANIUM/NITINOL/SILICONE
• 00844505014618 - REUTER BOBBIN VENT TUBE: 2025-02-10 REUTER BOBBIN VENT TUBE W/ HOLES 1.14MM ID FLUOROPLASTIC 60 PACK
• 10844505014585 - REUTER BOBBIN VENT TUBE: 2025-02-03 REUTER BOBBIN VENT TUBE W/HOLES 1.14MM ID FLUOROPLASTIC
• 10844505014592 - REUTER BOBBIN VENT TUBE: 2025-02-03 REUTER BOBBIN VENT TUBE W/ HOLES 1.14MM ID FLUOROPLASTIC 10 PACK
• 10844505014608 - REUTER BOBBIN VENT TUBE: 2025-02-03 REUTER BOBBIN VENT TUBE W/ HOLES 1.14MM ID FLUOROPLASTIC 30 PACK
• 00844505014335 - CUEVA DISSECTOR: 2024-11-25 CUEVA NO.1 DISSECTOR, DOUBLE-ENDED, STAINLESS STEEL
• 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