BR Surgical, LLC

Address:3500 Beachwood Ct Ste 107,Jacksonville,FL,32224,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

Cystoscope and accessories, flexible/rigid (FAJ) (7) HYSTEROSCOPE (AND ACCESSORIES) (HIH) (7) Nasopharyngoscope (flexible or rigid) (EOB) (2) Laparoscope, general & plastic surgery (GCJ) (1)

Premarket Exempt

No Yes

Clear

BR Surgical, LLC - 00857556008246 Catalog Number : BR946-4045-175

Device Description : Sinus Scope, autoclavable, Ø 4mm, 45º, 175mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008253 Catalog Number : BR946-4070-175

Device Description : Sinus Scope, autoclavable, Ø 4mm, 70º, 175mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008260 Catalog Number : BR953-5002-302

Device Description : Laparoscope, 4K, autoclavable, Ø 5.5mm, 0º, 302mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008277 Catalog Number : BR966-4000-302

Device Description : Cystoscope, autoclavable, Ø 4mm, 0º, 302mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008284 Catalog Number : BR966-4012-302

Device Description : Cystoscope, autoclavable, Ø 4mm, 12º, 302mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008291 Catalog Number : BR966-4030-302

Device Description : Cystoscope, autoclavable, Ø 4mm, 30º, 302mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008307 Catalog Number : BR966-4070-302

Device Description : Cystoscope, autoclavable, Ø 4mm, 70º, 302mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008314 Catalog Number : BR970-2912-302

Device Description : Hysteroscope, autoclavable, Ø 2.9mm, 12º, 302mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008321 Catalog Number : BR970-2930-302

Device Description : Hysteroscope, autoclavable, Ø 2.9mm, 30º, 302mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : No

Device Count : 1

BR Surgical, LLC - 00857556008338 Catalog Number : BR970-4000-302

Device Description : Hysteroscope, autoclavable, Ø 4mm, 0º, 302mm

Device Class : 2

Duns Number: 134781207

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : No

Device Count : 1

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