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

Gauge, Measuring (JYJ) (5) Instrument, Ent Manual Surgical (LRC) (5) REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL (ETA) (5)

Premarket Exempt

No Yes

Clear

OFFSET NANO ALTO TOTAL - 00844505013536 Catalog Number :

Device Description : OFFSET NANO ALTO TOTAL SIZERS INCLUDED TITANIUM/SILICONE

Device Class : 1

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETA, JYJ

Prescription Use : Yes

Device Count : 1

CENTERED ALTO TOTAL W/INTEGRATED SHOE - 00844505013543 Catalog Number :

Device Description : CENTERED ALTO TOTAL W/INTEGRATED SHOE/SIZERS INCLUDED TITANIUM/SILICONE

Device Class : 1

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETA, JYJ

Prescription Use : Yes

Device Count : 1

HA LITE ALTO TOTAL W/INTEGRATED SHOE - 00844505013550 Catalog Number :

Device Description : HA LITE ALTO TOTAL W/INTEGRATED SHOE SIZERS INCLUDED HA/TITANIUM/SILICONE

Device Class : 1

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETA, JYJ

Prescription Use : Yes

Device Count : 1

BOJRAB ALTO PRECUT - 00844505013567 Catalog Number :

Device Description : BOJRAB ALTO PRECUT TOTAL 5.00 - 6.25MM L SIZERS INCLUDED HA/TITANIUM/SILICONE

Device Class : 1

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETA, JYJ

Prescription Use : Yes

Device Count : 1

2 IN 1 ALTO - 00844505013574 Catalog Number :

Device Description : 2 IN 1 ALTO SIZERS INCLUDED HA/TITANIUM/SILICONE

Device Class : 1

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETA, JYJ

Prescription Use : Yes

Device Count : 1

CUEVA DISSECTOR, STRAIGHT - 00844505013581 Catalog Number :

Device Description : CUEVA DISSECTOR, STRAIGHT, STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

CUEVA DISSECTOR, RIGHT - 00844505013598 Catalog Number :

Device Description : CUEVA DISSECTOR, RIGHT, STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

CUEVA DISSECTOR, LEFT - 00844505013604 Catalog Number :

Device Description : CUEVA DISSECTOR, LEFT, STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

BOJRAB DISSECTOR, LARGE, ANGLED 115° - 00844505013611 Catalog Number :

Device Description : BOJRAB DISSECTOR, LARGE, ANGLED 115° 0.76MM X 3.27MM STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

BOJRAB DISSECTOR, MEDIUM, ANGLED 115° - 00844505013628 Catalog Number :

Device Description : BOJRAB DISSECTOR, MEDIUM, ANGLED 115° 0.76MM X 2.11MM STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

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