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) (3) Rasp (HTR) (3) Syringe, Piston (FMF) (2) System, Facet Screw Spinal Device (MRW) (2)

Premarket Exempt

Clear

ALARA Neuro Access Needle Kit - 00858406007389 Catalog Number :

Device Description : ALARA Neuro Access Needle 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 - 00858406007396 Catalog Number :

Device Description : ALARA Neuro Access Needle 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 - 00858406007419 Catalog Number :

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

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

Graftgun Universal Graft Delivery System - 00858406007426 Catalog Number :

Device Description : Graftgun Universal Graft Delivery System labeled with a different catalog for In Graftgun Universal Graft Delivery System labeled with a different catalog for Integrity Implants to distribute.

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Graftgun Universal Graft Delivery System - Cartridge Kit - 00858406007433 Catalog Number :

Device Description : Graftgun Universal Graft Delivery System - Cartridge Kit labeled with new catalo Graftgun Universal Graft Delivery System - Cartridge Kit labeled with new catalog number for distribution by Integrity Implants

Device Class : 2

Duns Number: 004095409

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

GraftRasp Teeth and Set Screw- Straight - 00858406007563 Catalog Number :

Device Class : 1

Duns Number: 004095409

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

Flexible Pusher Tip and Set Screw - 00858406007600 Catalog Number :

Device Class : 1

Duns Number: 004095409

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

GraftRasp Teeth and Set Screw - Bladed - 00858406007709 Catalog Number :

Device Class : 1

Duns Number: 004095409

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

ION Facet Screw System - 00858406007952 Catalog Number :

Device Description : ION Facet Screw - 5.5 x 10mm

Device Class : U

Duns Number: 004095409

Premarket Exempt : No

Product Code : MRW

Prescription Use : Yes

Device Count : 1

ION Facet Screw System - 00858406007969 Catalog Number :

Device Description : ION Facet Screw - 5.5 x 15mm

Device Class : U

Duns Number: 004095409

Premarket Exempt : No

Product Code : MRW

Prescription Use : Yes

Device Count : 1

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