BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

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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

Gauze/Sponge, Internal, X-Ray Detectable (GDY) (4) Thermometer, Electronic, Clinical (FLL) (3) Vinyl Patient Examination Glove (LYZ) (3)

Premarket Exempt

No Yes

Clear

AmerisourceBergen - 00368001109109 Catalog Number :

Device Description : Vinyl Exam Gloves Stretch Powder Free (Medium)

Device Class :

Duns Number: 985523874

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 150

AmerisourceBergen - 00368001109116 Catalog Number :

Device Description : Vinyl Exam Gloves Stretch Powder Free (Large)

Device Class :

Duns Number: 985523874

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 150

AmerisourceBergen - 00368001109123 Catalog Number :

Device Description : Vinyl Exam Gloves Stretch Powder Free (X-Large)

Device Class :

Duns Number: 985523874

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 130

AmerisourceBergen - 00368001110013 Catalog Number :

Device Description : Digital Thermometer, waterproof - Rigid Tip

Device Class : 2

Duns Number: 985523874

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

AmerisourceBergen - 00368001110020 Catalog Number :

Device Description : Digital Thermometer, waterproof - Flexible Tip

Device Class : 2

Duns Number: 985523874

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

AmerisourceBergen - 00368001110037 Catalog Number :

Device Description : Thermometer probe covers

Device Class :

Duns Number: 985523874

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 50

AmerisourceBergen - 00368001111010 Catalog Number :

Device Description : X-Ray Detectable Sponges Sterile 4in X 4in

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 10

AmerisourceBergen - 00368001111027 Catalog Number :

Device Description : X-Ray Detectable Sponges 4in X 4in Non-Sterile

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 100

AmerisourceBergen - 00368001112017 Catalog Number :

Device Description : Laparotomy Sponges X-Ray Detectable pre-washed sterile 12" X 12"

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 5

AmerisourceBergen - 00368001112024 Catalog Number :

Device Description : Laparatomy Sponges X-Ray Detectable - Sterile 18" X 18"

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 5

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