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) REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL (ETA) (1)

Premarket Exempt

No Yes

Clear

TOTAL TILT TOP HEAD NOTCHED - 00844505000314 Catalog Number :

Device Description : TOTAL TILT TOP 3.50MM HEAD NOTCHED 1MM DIA X 8MM L HA/OTOSIL

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

PARTIAL TILT TOP 3MM HEAD CENTERED - 00844505000321 Catalog Number :

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

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

PARTIAL TILT TOP 4MM HEAD CENTERED - 00844505000338 Catalog Number :

Device Description : PARTIAL TILT TOP 4MM HEAD CENTERED 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 TILT TOP 3.25MM HEAD OFFSET - 00844505000345 Catalog Number :

Device Description : PARTIAL TILT TOP 3.25MM 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 TILT TOP 4MM HEAD OFFSET - 00844505000352 Catalog Number :

Device Description : PARTIAL TILT TOP 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 TILT TOP 3.25MM HEAD NOTCHED - 00844505000369 Catalog Number :

Device Description : PARTIAL TILT TOP 3.25MM HEAD NOTCHED OTOSIL 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 TILT TOP 4MM HEAD NOTCHED - 00844505000376 Catalog Number :

Device Description : PARTIAL TILT TOP 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

PARTIAL TILT TOP HEAD VINCENT TYPE - 00844505000383 Catalog Number :

Device Description : PARTIAL TILT TOP HEAD VINCENT TYPE 1.12MM ID X 6MM L HA/OTOSIL/TI

Device Class : 2

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB

Prescription Use : Yes

Device Count : 1

PARTIAL TILT TOP 3.50MM HEAD OFFSET - 00844505000390 Catalog Number :

Device Description : PARTIAL TILT TOP 3.50MM HEAD OFFSET OTOSIL 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 TILT TOP 3.50MM HEAD NOTCHED - 00844505000406 Catalog Number :

Device Description : PARTIAL TILT TOP 3.50MM 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

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