AESCULAP IMPLANT SYSTEMS, LLC

Address:9999 HAMILTON BLVD., BLDG 8,Breinigsville,PA,18031,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

TRAY, SURGICAL, INSTRUMENT (FSM) (10)

Premarket Exempt

No Yes

Clear

AESCULAP - 04046955076871 Catalog Number : US094

Device Description : LIFTING PLATFORM 4"

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955076888 Catalog Number : US095

Device Description : LIFTING PLATFORM 5"

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955076895 Catalog Number : US096

Device Description : LIFTING PLATFORM 6"

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955076901 Catalog Number : US097

Device Description : LIFTING PLATFORM 8"

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955076918 Catalog Number : US098

Device Description : LIFTING PLATFORM 10"

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955080984 Catalog Number : ME936

Device Description : ACTIV L DISTRACTION/INSERTION TRAY BASE

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955080991 Catalog Number : ME937

Device Description : ACTIV L DISTRACTION/INSERTION TRIALCADDY

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955081004 Catalog Number : ME938

Device Description : ACTIV L DISTRACTION/INSERTION TRAY TOP

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955081011 Catalog Number : ME940

Device Description : ACTIV L DISTRACTION/INSERTION TRAY LID

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AESCULAP - 04046955081028 Catalog Number : ME941

Device Description : ACTIV L DISCECTOMY TRAY BASE

Device Class : 1

Duns Number: 622600992

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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