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,Nonresorbable For External Use (NAB) (5) Gauze/Sponge, Internal, X-Ray Detectable (GDY) (5)

Premarket Exempt

No Yes

Clear

AmerisourceBergen - 00368001112062 Catalog Number :

Device Description : Laparotomy Sponges Non-sterile, Pre-washed 4" X 18"

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 5

AmerisourceBergen - 00368001112079 Catalog Number :

Device Description : Laparotomy Sponges Non-sterile pre washed 18" X 18"

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 5

AmerisourceBergen - 00368001112086 Catalog Number :

Device Description : Laparotomy Sponges X-Ray Detectable Pre-washed Sterile

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 5

AmerisourceBergen - 00368001112093 Catalog Number :

Device Description : Laparotomy Sponges X-Ray Detectable Pre-washed Sterile

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 5

AmerisourceBergen - 00368001112109 Catalog Number :

Device Description : Laparotomy Sponges X-Ray Detectable Pre-washed Sterile

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 5

Amerisource Bergen - 00368001113014 Catalog Number :

Device Description : Non-adherent Pads Sterile 3in x 4in

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 100

Amerisource Bergen - 00368001113021 Catalog Number :

Device Description : Non adherent Pads sterile 3in x 8in

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 50

AmerisourceBergen - 00368001113038 Catalog Number :

Device Description : Non-adherent Pads non-sterile 3in X 8in

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

AmerisourceBergen - 00368001113045 Catalog Number :

Device Description : Non-adherent Pads 8 in X 10 in (non-sterile)

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 125

Amerisource Bergen - 00368001113052 Catalog Number :

Device Description : Non-adherent Pads Sterile 2in X 3in

Device Class :

Duns Number: 985523874

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 100

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