PARTIAL TILT TOP 3.50MM HEAD OFFSET

GUDID 00844505000390

Ossicular prosthesis, partial

Primary Device ID	00844505000390
NIH Device Record Key	53eef316-3684-45d3-9201-d154eabda6de
Commercial Distribution Status	In Commercial Distribution
Brand Name	PARTIAL TILT TOP 3.50MM HEAD OFFSET
Version Model Number	257
Company DUNS	030849173
Company Name	Grace Medical, Inc.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
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	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

Device Issuing Agency	Device ID
GS1	00844505000390 [Primary]

ETB	PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Steralize Prior To Use	false
Device Is Sterile	true

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