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

Instrument, Ent Manual Surgical (LRC) (5) Gauge, Measuring (JYJ) (3) Knife, Ear (JYO) (2) PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT (ETB) (1) REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL (ETA) (1) Replacement, Ossicular Prosthesis, Total (ETA) (1)

Premarket Exempt

No Yes

Clear

BOJRAB DISSECTOR, SMALL, ANGLED 115° - 00844505013635 Catalog Number :

Device Description : BOJRAB DISSECTOR, SMALL, ANGLED 115° 0.76MM X 1.54MM STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

BOJRAB DISSECTION ROUND KNIFE, 2.54MM DIA - 00844505013642 Catalog Number :

Device Description : BOJRAB DISSECTION ROUND KNIFE ANGLED 35°, 2.54MM DIA. STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : JYO

Prescription Use : Yes

Device Count : 1

BOJRAB DISSECTION SICKLE KNIFE - 00844505013659 Catalog Number :

Device Description : BOJRAB DISSECTION SICKLE KNIFE 6.35MM CURVED BLADE STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : JYO

Prescription Use : Yes

Device Count : 1

CENTERED ALTO TOTAL - 00844505013666 Catalog Number :

Device Description : CENTERED ALTO TOTAL 15MM LENGTH, 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 - 00844505013673 Catalog Number :

Device Description : HA LITE ALTO TOTAL 15MM LENGTH, SIZERS INCLUDED HA/TITANIUM/SILICONE

Device Class : 1

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETA, JYJ

Prescription Use : Yes

Device Count : 1

CENTERED ALTO PARTIAL - 00844505013680 Catalog Number :

Device Description : CENTERED ALTO PARTIAL 7MM LENGTH, SIZERS INCLUDED TITANIUM/SILICONE

Device Class : 1

Duns Number: 030849173

Premarket Exempt : No

Product Code : ETB, JYJ

Prescription Use : Yes

Device Count : 1

BOJRAB DISSECTOR, LARGE, ANGLED 24° - 00844505013697 Catalog Number :

Device Description : BOJRAB DISSECTOR, LARGE, ANGLED 24° 2.1MM X 1.8MM STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

BOJRAB DISSECTOR, MEDIUM, ANGLED 25° - 00844505013703 Catalog Number :

Device Description : BOJRAB DISSECTOR, MEDIUM, ANGLED 25° 0.76MM X 1.8MM STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

BOJRAB DISSECTOR, SMALL, ANGLED 20° - 00844505013710 Catalog Number :

Device Description : BOJRAB DISSECTOR, SMALL, ANGLED 20° 0.57MM STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

BOJRAB DISSECTION NEEDLE, ANGLED 20° - 00844505013727 Catalog Number :

Device Description : BOJRAB DISSECTION NEEDLE, ANGLED 20° 2.0MM STAINLESS STEEL

Device Class : 1

Duns Number: 030849173

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

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