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

Nerve Block Tray (OGJ) (6) Mask, Surgical (FXX) (3) Manometer, Spinal-Fluid (FMJ) (1)

Premarket Exempt

No Yes

Clear

Busse Hospital Disposables - 00849233000759 Catalog Number : 6477

Device Description : Nerve Block Tray

Device Class : 2

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233000780 Catalog Number : 5553R2

Device Description : Nerve Block Tray

Device Class : 2

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233000926 Catalog Number : 370

Device Description : Isolation Masks

Device Class :

Duns Number: 002418234

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Busse Hospital Disposables - 00849233000933 Catalog Number : 371

Device Description : Procedural Masks

Device Class : 2

Duns Number: 002418234

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Busse Hospital Disposables - 00849233000957 Catalog Number : 373

Device Description : Fluid Resistant Masks with Face Shields

Device Class :

Duns Number: 002418234

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Busse Hospital Disposables - 00849233000971 Catalog Number : 5158

Device Description : Lumbar Puncture Tray (Bandeja de Puncion Lumbar )

Device Class :

Duns Number: 002418234

Premarket Exempt : No

Product Code : FMJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233001008 Catalog Number :

Device Description : Pump Refill Kit

Device Class : 2

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233001015 Catalog Number : 8795

Device Description : Epidural Pain Tray

Device Class : 2

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233001053 Catalog Number : 1422R1

Device Description : Nerve Block Kit

Device Class :

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

Busse Hospital Disposables - 00849233001060 Catalog Number : 1728R1

Device Description : Epidural Tray

Device Class :

Duns Number: 002418234

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

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