Southmedic Incorporated

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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

BLADE, SCALPEL (GES) (7) Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) (HOY) (2) RETENTION DEVICE, SUTURE (KGS) (1)

Premarket Exempt

No Yes

Clear

Dynamic Tissue Systems™ - 00620974001867 Catalog Number : CZE07

Device Description : ABRA Silicone Cord Elastomer

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : KGS

Prescription Use : Yes

Device Count : 5

BetterShield™ - 00620974002048 Catalog Number : MXFS-25

Device Description : Disposable Face Shield

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : Yes

Device Count : 25

BetterShield™ - 00620974002055 Catalog Number : MXFS-100

Device Description : Disposable Face Shield

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : Yes

Device Count : 50

Polymer Coated Blades - 00620974002130 Catalog Number : 73-0415

Device Description : #15 Sterile Blade

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 50

Polymer Coated Blades - 00620974002147 Catalog Number : 73-0420

Device Description : #20 Sterile Blade

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 50

Disposable Scalpel - 00620974002154 Catalog Number : 73-0110

Device Description : #10 Sterile Disposable Scalpel

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 10

SPSS Disposable Scalpels - 00620974002161 Catalog Number : 73-9010

Device Description : Safety Scalpel with Southmedic Plus Surgical Blade

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 10

Disposable Scalpel - 00620974002178 Catalog Number : 73-0111

Device Description : #11 Sterile Disposable Scalpel

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 10

SPSS Disposable Scalpels - 00620974002185 Catalog Number : 73-9011

Device Description : Safety Scalpel with Southmedic Plus Surgical Blade

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 10

Disposable Scalpel - 00620974002192 Catalog Number : 73-0115

Device Description : #15 Sterile Disposable Scalpel

Device Class :

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 10

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