PELICAN FEMININE HEALTHCARE LIMITED

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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

Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (5) Rongeur (HTX) (3) Speculum, Ent (EPY) (2)

Premarket Exempt

Yes

Clear

Single Use Surgical Professional - 05055299104415 Catalog Number : S261

Device Description : Kerrison Punch 2mm x 200mm @ 45 Degrees DUO Kerrison Punch 2mm x 200mm @ 45 Degrees DUO

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : HTX

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299104439 Catalog Number : S262

Device Description : Kerrison Punch 3mm x 200mm @ 45 Degrees DUO Kerrison Punch 3mm x 200mm @ 45 Degrees DUO

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : HTX

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299104484 Catalog Number : S238

Device Description : Thudichum Specula Size 4 Thudichum Specula Size 4

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299104507 Catalog Number : S239

Device Description : Thudichum Specula Size 3 Thudichum Specula Size 3

Device Class : 1

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299104620 Catalog Number : S240

Device Description : Suction 9fg 15cm with Sheffield Clip Suction 9fg 15cm with Sheffield Clip

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299104729 Catalog Number : S284

Device Description : Rounded Long Suction 12fg 35cm Rounded Long Suction 12fg 35cm

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299104903 Catalog Number : S329

Device Description : Rounded Long Suction 12fg 40cm Rounded Long Suction 12fg 40cm

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299105160 Catalog Number : S340

Device Description : Frazier Suction 15fg 9cm Frazier Suction 15fg 9cm

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299105221 Catalog Number : S343

Device Description : Fenestrated Rounded Frazier 12fg 13cm Fenestrated Rounded Frazier 12fg 13cm

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

Single Use Surgical Professional - 05055299105474 Catalog Number : S367

Device Description : Kerrison Punch 2mm x 170mm @ 90 Degrees Kerrison Punch 2mm x 170mm @ 90 Degrees

Device Class :

Duns Number: 239505063

Premarket Exempt : Yes

Product Code : HTX

Prescription Use : No

Device Count : 1

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