Grace Medical, Inc.

Address:8500 WOLF LAKE DR. SUITE 110,Memphis,TN,38133,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT (ETB) (9) Prosthesis, Partial Ossicular Replacement (ETB) (1)

Premarket Exempt

No Yes

Clear

PARTIAL 3MM CENTERED HEAD - 00844505000413 Catalog Number :

Device Description : PARTIAL 3MM CENTERED HEAD 1.12MM ID X 6MM L HA/OTOSIL

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

STRANICK PARTIAL TILT-TOP 3MM HEAD - 00844505000420 Catalog Number :

Device Description : STRANICK PARTIAL TILT-TOP 3MM HEAD 1.12MM ID X 6.1MM L TITANIUM/OTOSIL

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

PARTIAL 4MM CENTERED HEAD - 00844505000437 Catalog Number :

Device Description : PARTIAL 4MM CENTERED HEAD 1.12MM ID X 6MM L HA/OTOSIL

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

PARTIAL 4MM HEAD OFFSET - 00844505000444 Catalog Number :

Device Description : PARTIAL 4MM HEAD OFFSET 1.12MM ID X 6MM L HA/OTOSIL

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

PARTIAL 4MM HEAD NOTCHED - 00844505000451 Catalog Number :

Device Description : PARTIAL 4MM HEAD NOTCHED 1.12MM ID X 6MM L HA/OTOSIL

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

FLUOROPLASTIC PISTON - 00844505000468 Catalog Number :

Device Description : FLUOROPLASTIC PISTON 0.3MM DIA X 4.50MM L

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

FLUOROPLASTIC PISTON - 00844505000475 Catalog Number :

Device Description : FLUOROPLASTIC PISTON 0.3MM DIA X 5.00MM L

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

FLUOROPLASTIC PISTON - 00844505000482 Catalog Number :

Device Description : FLUOROPLASTIC PISTON 0.3MM DIA X 6.00MM L

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

GRACE MEDICAL FLUOROPLASTIC PISTON - 00844505000499 Catalog Number :

Device Description : FLUOROPLASTIC PISTON 0.4MM DIA X 3.50MM L

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

GRACE MEDICAL FLUOROPLASTIC PISTON - 00844505000505 Catalog Number :

Device Description : FLUOROPLASTIC PISTON 0.4MM DIA X 4.00MM L

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

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