LACEY MANUFACTURING COMPANY, LLC

Address:1146 Barnum Ave,BRIDGEPORT,CT,06610,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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (7) Neurosurgical Nerve Locator (PDQ) (3)

Premarket Exempt

Clear

BE-ST Bipolar Forceps - 00853508002034 Catalog Number :

Device Description : Electrosurgical Bipolar Device

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BE-ST Bipolar Forceps - 00853508002058 Catalog Number :

Device Description : Bayonet Bipolar Forceps, Angled Tip

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BE-ST Bipolar Forceps - 00853508002065 Catalog Number :

Device Description : Bayonet Bipolar Forceps, Straight Tip

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BE-ST ElectroCautery Pencil - 00853508002072 Catalog Number :

Device Description : Bayonet ElectroCautery Pencil

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BE-ST Bipolar Forceps - 00853508002096 Catalog Number :

Device Description : Bayonet Bipolar Forceps Straight Tip

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BE-ST Bipolar Forceps Straight - 00853508002119 Catalog Number : 1590-07

Device Description : Bayonet Bipolar Forceps Straight Tip

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BE-ST ElectroCautery Pencil - 00853508002140 Catalog Number :

Device Description : Bayonet ElectroCautery Pencil

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BE-ST NIM PAK Needle Bevel - 00853508002270 Catalog Number : PK1006

Device Description : Pedicle Access Kit Needle with Neural Integrity Monitor

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

BE-ST NIM PAK Needle Trocar - 00853508002287 Catalog Number : PK1007

Device Description : Pedicle Access Kit Needle with Neural Integrity Monitor

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

BE-ST NIM XPAK Needle Bevel - 00853508002294 Catalog Number : PK1008

Device Description : Pedicle Access Kit Needle Trocar

Device Class : 2

Duns Number: 958212029

Premarket Exempt : No

Product Code : PDQ

Prescription Use : Yes

Device Count : 1

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