SURGENTEC, LLC

Address:911 Clint Moore Rd,Boca Raton,FL,33487,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

Neurosurgical Nerve Locator (PDQ) (8) Filler, Bone Void, Calcium Compound (MQV) (2)

Premarket Exempt

Clear

OsteoFlo Synthetic NanoPutty Cartridge- 5cc - 00858406007228 Catalog Number :

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoFlo Synthetic NanoPutty Cartridge- 10cc - 00858406007235 Catalog Number :

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

ALARA Neuro Access Needle Kit - 00858406007297 Catalog Number :

Device Description : ALARA Neuro Access Needle Kit - Bevel Tip

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

ALARA Neuro Access Needle Kit - 00858406007303 Catalog Number :

Device Description : ALARA Neuro Access Needle Kit Two Pack - Diamond Tip

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

ALARA Neuro Access Needle Kit - 00858406007310 Catalog Number :

Device Description : ALARA Neuro Access Needle Kit Two Pack - Diamond & Bevel Tip

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

ALARA Neuro Access Needle Kit - 00858406007327 Catalog Number :

Device Description : ALARA Neuro Access Needle Kit Two Pack - Bevel Tip

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

ALARA Neuro Access Needle Kit - 00858406007334 Catalog Number :

Device Description : ALARA Neuro Access Needle Kit with Extension Handle- Diamond Tip

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

ALARA Neuro Access Needle Kit - 00858406007341 Catalog Number :

Device Description : ALARA Neuro Access Needle Kit with Extension Handle- Bevel Tip

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

ALARA Neuro Access Needle Kit - 00858406007365 Catalog Number :

Device Description : ALARA Neuro Access Needle - Diamond Tip

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

ALARA Neuro Access Needle Kit - 00858406007372 Catalog Number :

Device Description : ALARA Neuro Access Needle - Bevel Tip

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

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