STANDARD BARIATRICS, INC

Address:4362 Glendale Milford Road,Cincinnati,OH,45242,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

Laparoscope, General & Plastic Surgery (GCJ) (3) Staple, Implantable (GDW) (3) Stapler, Surgical (GAG) (3) Tubes, Gastrointestinal (And Accessories) (KNT) (3)

Premarket Exempt

Clear

Standard Clamp, Disposable - 00851677007003 Catalog Number : SCD25-1

Device Class :

Duns Number: 091278068

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Standard Clamp, Disposable - 00851677007027 Catalog Number :

Device Class : 2

Duns Number: 091278068

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Standard Trocar - 00851677007041 Catalog Number : ST19

Device Class : 2

Duns Number: 091278068

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Standard Bougie - 00851677007058 Catalog Number :

Device Class : 2

Duns Number: 091278068

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Standard Bougie, 38Fr - 00851677007065 Catalog Number :

Device Class : 2

Duns Number: 091278068

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Titan SGS Standard Gastric Stapler - 00851677007089 Catalog Number :

Device Class :

Duns Number: 091278068

Premarket Exempt : No

Product Code : GDW, GAG

Prescription Use : Yes

Device Count : 1

TITAN Standard Power Unit - 00851677007096 Catalog Number :

Device Class : 2

Duns Number: 091278068

Premarket Exempt : No

Product Code : GDW, GAG

Prescription Use : Yes

Device Count : 1

Standard Bougie Handpump - 00851677007119 Catalog Number :

Device Class : 2

Duns Number: 091278068

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Titan SGS Standard Gastric Stapler - 00851677007133 Catalog Number :

Device Class :

Duns Number: 091278068

Premarket Exempt : No

Product Code : GAG, GDW

Prescription Use : Yes

Device Count : 1

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