AMERICAN CONTRACT SYSTEMS, INC.

Address:11600 Adelmo Ln,Fort Myers,FL,33966,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

General surgery tray (LRO) (9) Cardiovascular procedure kit (OEZ) (1)

Premarket Exempt

Yes

Clear

ACS - 00191072000309 Catalog Number :

Device Description : MAJOR PROCEDURE PACK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

ACS - 00191072000316 Catalog Number :

Device Description : MINOR PROCEDURE PACK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

ACS - 00191072000323 Catalog Number :

Device Description : MAJOR VASCULAR

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

ACS - 00191072000330 Catalog Number :

Device Description : NEURO PACK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

ACS - 00191072000347 Catalog Number :

Device Description : OPEN HEART DRAPE - TOWEL PACK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

ACS - 00191072000354 Catalog Number :

Device Description : OPEN HEART ACCESSORY PACK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

ACS - 00191072000361 Catalog Number :

Device Description : OPEN HEART BASIN PACK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : OEZ

Prescription Use : No

Device Count : 1

ACS - 00191072000378 Catalog Number :

Device Description : PAIN PACK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

ACS - 00191072000385 Catalog Number :

Device Description : PLASTIC PACK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

ACS - 00191072000392 Catalog Number :

Device Description : PACEMAKER PK

Device Class : 2

Duns Number: 010334675

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

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