ROBERT BUSSE & CO., INC.

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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

Manometer, Spinal-Fluid (FMJ) (4) Anesthesia Conduction Kit (CAZ) (2) Arthrogram Tray (OII) (1) Clamp, Umbilical (HFW) (1) Nerve Block Tray (OGJ) (1) Wound Dressing Kit (MCY) (1)

Premarket Exempt

No Yes

Clear

Busse Hospital Disposables - 00849233017962 Catalog Number : 3897

Device Description : Arthrogram Tray

Device Class :

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : OII

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233017986 Catalog Number : 5114

Device Description : Dressing Change Kit

Device Class : 2

Duns Number: 002418234

Premarket Exempt : No

Product Code : MCY

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233017993 Catalog Number : 5216

Device Description : Caudal Tray

Device Class :

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : CAZ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233018006 Catalog Number : 5235

Device Description : Pediatric Infant Safety Lumbar Puncture Tray w/ 21 g x 21 1/2" spinal Needle

Device Class :

Duns Number: 002418234

Premarket Exempt : No

Product Code : FMJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233018013 Catalog Number : 5236

Device Description : Pediatric Infant Safety Lumbar Puncture Tray w/ 22 g x 21 1/2" spinal Needle

Device Class :

Duns Number: 002418234

Premarket Exempt : No

Product Code : FMJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233018020 Catalog Number : 5237

Device Description : Safety Lumbar Puncture Tray with 18 Gauge x 3 1/2" Spinal Needle & Manometer

Device Class :

Duns Number: 002418234

Premarket Exempt : No

Product Code : FMJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233018037 Catalog Number : 5238

Device Description : Safety Lumbar Puncture Tray w/ 20 Gauge x 3 1/2" Spinal Needle & Manometer

Device Class :

Duns Number: 002418234

Premarket Exempt : No

Product Code : FMJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233018044 Catalog Number : 2861

Device Description : Sterile Nerve Block Tray

Device Class : 2

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : CAZ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233018051 Catalog Number : 5187

Device Description : Epidural Tray

Device Class :

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233018105 Catalog Number : 385

Device Description : Umbilical Cord Clamp, Bulk

Device Class : 2

Duns Number: 002418234

Premarket Exempt : No

Product Code : HFW

Prescription Use : No

Device Count : 1

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