WILDCAT PRO, 4.00MM L

GUDID 00844505011259

WILDCAT PRO 4.00MM LENGTH HA/TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, total

• Primary Device ID: 00844505011259
• NIH Device Record Key: cd4b3762-0aae-4dfd-9fc4-8ea83c283365
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WILDCAT PRO, 4.00MM L
• Version Model Number: 709-400
• 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: 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	00844505011259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061853

FDA Product Code

• ETA: Replacement, Ossicular Prosthesis, Total

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: 2020-04-27
• Device Publish Date: 2017-07-13

Devices Manufactured by Grace Medical, Inc.

• 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
• 00844505014564 - GRACE MEDICAL FLUOROPLASTIC PISTON: 2025-08-13 FLUOROPLASTIC PISTON 0.6MM DIA X 4.75MM L
• 00844505014670 - GRACE MEDICAL FLUOROPLASTIC PISTON: 2025-08-13 FLUOROPLASTIC PISTON 0.6MM DIA X 5.75MM L
• 00844505014663 - OFFSET TITANIUM WILDCAT ALTO: 2025-07-25 OFFSET TITANIUM WILDCAT ALTO™ SIZERS INCLUDED TITANIUM/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