ATC TECHNOLOGIES, INC.

Address:30-B Upton Drive,Wilmington,MA,01887,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

Laparoscope, General & Plastic Surgery (GCJ) (8) Device, Biopsy, Endomyocardial (DWZ) (2)

Premarket Exempt

Clear

Modulap - 00817428020103 Catalog Number :

Device Description : ASU1255T Laparoscopic irrigation/aspiration cannula; 10mm x33cm, endoscopic pool ASU1255T Laparoscopic irrigation/aspiration cannula; 10mm x33cm, endoscopic pool tip, reusable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Modulap - 00817428020110 Catalog Number :

Device Description : ASU1260T Laparoscopic irrigation/aspiration cannula; 5mm x33cm, microprobe tip, reusable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Modulap - 00817428020127 Catalog Number :

Device Description : ASU1245T Laparoscopic irrigation/aspiration cannula; 5mm x45cm (bariatric length ASU1245T Laparoscopic irrigation/aspiration cannula; 5mm x45cm (bariatric length) with holes, reusable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Modulap - 00817428020134 Catalog Number :

Device Description : ASU1281T Monopolar electrode, laparoscopic, reusable, J-hook tip

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Modulap - 00817428020141 Catalog Number :

Device Description : ASU1282T Monopolar electrode, laparoscopic, reusable, L-hook tip, reusable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Modulap - 00817428020158 Catalog Number :

Device Description : ASU1284T Monopolar electrode, laparoscopic, reusable, spatula tip, reusable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Modulap - 00817428020165 Catalog Number :

Device Description : ASU1287T Monopolar electrode, laparoscopic, reusable, needle tip, reusable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Modulap - 00817428020172 Catalog Number :

Device Description : ASU1258T Sliding Sheath for Monopolar electrode, laparoscopic, reusable, reusable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

SparrowHawk - 00817428020189 Catalog Number :

Device Description : 5030 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 50cm, Max-Curve, Disposable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : DWZ

Prescription Use : Yes

Device Count : 1

SparrowHawk - 00817428020202 Catalog Number :

Device Description : 5031 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 50cm, Max-Curve, Disposable

Device Class : 2

Duns Number: 023131605

Premarket Exempt : No

Product Code : DWZ

Prescription Use : Yes

Device Count : 1

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