SYNERGETICS USA, INC.

Address:3845 Corporate Centre Dr,O Fallon,MO,63368,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

Endoilluminator (MPA) (8) Kit, Surgical Instrument, Disposable (KDD) (2)

Premarket Exempt

No Yes

Clear

Synergetics - 10841305100647 Catalog Number : 56.02.23

Device Description : 23ga Endo Illuminator (Eckardt Trocar Compatible)

Device Class : 2

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305100654 Catalog Number : 56.02.23P

Device Description : 23ga Endo Illuminator (Eckardt Trocar Compatible)

Device Class : 2

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305100661 Catalog Number : 56.02.25

Device Description : 25ga Endo Illuminator

Device Class : 2

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305100678 Catalog Number : 56.02.25PS

Device Description : Stiff 25ga Endo Illuminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305100685 Catalog Number : 56.02.27P

Device Description : 27ga ONE-STEP™ Endo Illuminator

Device Class : 2

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305100692 Catalog Number : 56.02P

Device Description : Endo Illuminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305100760 Catalog Number : 56.12.25P

Device Description : 25ga Wide Field Corona Endo Illuminator

Device Class : 2

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305100838 Catalog Number : 56.21.23P

Device Description : 23ga Wide Field Endo Illuminator

Device Class : 2

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101064 Catalog Number : 18060

Device Description : I-PACK Injection Kit

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101071 Catalog Number : 18061

Device Description : I-PACK Injection Kit with Drape

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : Yes

Device Count : 1

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