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Grace Medical, Inc.

United States·US-MF-000026047

Last updated September 17, 2026

Information

Country: United States
Address: 8500 Wolf Lake Drive, Memphis, United States
Website: gracemedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(866)472-2363
PRRC Contact: Thomas Fearnley
EUDAMED SRN: US-MF-000026047
FDA FEI Number: 1000022662
DUNS Number: 030849173

Catalogue (1029)

Page 5 of 21

Device	Model / Reference	Registries	Class	Status
Precise Centered Total	705-325	FDA UDI	Class II	Active
Pope Vent Tube	525-646	FDA UDI	Class II	Active
Ha Total Strut	191	FDA UDI	Class II	Active
Shepard Grommet Vent Tube	510-021	FDA UDI	Class II	Active
Robinson Bucket Handle	422-400	FDA UDI	Class II	Active
Offset Alto Partial	650-M1	FDA UDI	Class II	Active
Lippy Bucket Handle W/Notch	423-400	FDA UDI	Class II	Active
Reuter Bobbin Vent Tube	520-681	FDA UDI	Class II	Active
Shepard Grommet Vent Tube W/Tab	525-042	FDA UDI	Class II	Unknown
Precise Centered Total	705-550	FDA UDI	Class II	Active
Grace Medical Straight Vent Tube	520-072	FDA UDI	Class II	Active
Offset Nano Alto Total W/Integrated Shoe	607	FDA UDI	Class II	Unknown
Gantz Alto Total	611B	FDA UDI	Class II	Active
Owens Assure	602-600	FDA UDI	Class II	Active
Precise Owens Assure Partial	652-450	FDA UDI	Class II	Active
Canoe Vent Tube	510-461	FDA UDI	Class II	Unknown
Titanium Piston	460-550	FDA UDI	Class II	Active
Grace Piston	412-600	FDA UDI	Class II	Active
Precise Ha Lite Total	720-325	FDA UDI	Class II	Active
Precise Byte	752-175	FDA UDI	Class II	Active
Precise Offset Total	700-375	FDA UDI	Class II	Active
Meiti Piston	418-400	FDA UDI	Class II	Active
Modified Armstrong Grommet	520-272	FDA UDI	Class II	Active
Armstrong Vent Tube	525-503	FDA UDI	Class II	Active
Precise Ha Lite Total	720-400	FDA UDI	Class II	Active
Precise Ha Lite Partial	770-375	FDA UDI	Class II	Active
Precise Centered Total	705-600	FDA UDI	Class II	Active
Shepard Grommet Vent Tube	525-041	FDA UDI	Class II	Active
Grace Medical Fluoroplastic Piston	402-475	FDA UDI	Class II	Active
Donaldson Vent Tube	525-052	FDA UDI	Class II	Active
DragonFly™ Skinny BUR, 100MM x 0.6MM	951-100-006-SB	FDA UDI	Class I	Active
Precise Offset Partial	750-400	FDA UDI	Class II	Active
EndoEar™ SUCTION	1.92.03	EUDAMEDFDA UDI	Class I	Active
Ha Partial Strut	190-390	FDA UDI	Class II	Active
Total Tilt Top Head Offset	202	FDA UDI	Class II	Active
Precise Ha Lite Total	720-500	FDA UDI	Class II	Active
Paparella Vent Tube	510-075	FDA UDI	Class II	Active
Precise Owens Assure Partial	652-400	FDA UDI	Class II	Active
Lippy Bucket Handle W/Notch	421-350	FDA UDI	Class II	Active
Bojrab Dissector, Medium, Angled 90°	999-DB6	FDA UDI	Class I	Active
Bojrab Dissector, Medium, Angled 20°	999-DB2	FDA UDI	Class I	Active
Titanium Piston	460-400	FDA UDI	Class II	Active
Meiti Piston	418-450	FDA UDI	Class II	Active
Precise Offset Partial	750-450	FDA UDI	Class II	Active
Miami Is Coupler Partial – Long	761	FDA UDI	Class II	Active
Bojrab Dissection Sickle Knife	999-DB9	EUDAMEDFDA UDI	Class I	Active
Grace Medical Fluoroplastic Piston	402-550	FDA UDI	Class II	Active
Grace Medical Titanium Round Wire Piston	463-475	FDA UDI	Class II	Active
Ha Alto Total	620	FDA UDI	Class II	Active
Grace Piston	453-500	FDA UDI	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 3, 2026	Z-2308-2026	—	open, classified	Due to incorrect functional length on device labeling.