PHARMACIA & UPJOHN COMPANY LLC

Address:7000 PORTAGE RD.,KALAMAZOO,MI,49001,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

Agent, absorbable hemostatic, collagen based (LMF) (4) APPLICATOR, VAGINAL (HGD) (3) IMPLANT, ORBITAL, EXTRA-OCULAR (HQX) (1) surgical film (OOD) (1)

Premarket Exempt

No Yes

Clear

Gelfilm - 00300090283018 Catalog Number :

Device Description : Anti-adhesion dressing, bioabsorbable

Device Class : 2

Duns Number: 618054084

Premarket Exempt : Yes

Product Code : OOD

Prescription Use : Yes

Device Count : 1

Gelfilm - 00300090297015 Catalog Number :

Device Description : Anti-adhesion dressing, bioabsorbable

Device Class : 2

Duns Number: 618054084

Premarket Exempt : Yes

Product Code : HQX

Prescription Use : Yes

Device Count : 1

GEL-FLOW™ NT - 00300091040016 Catalog Number :

Device Description : Absorbable Hemostatic Sponge, Collagen Based

Device Class : 3

Duns Number: 618054084

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

GEL-FLOW KIT - 00300092250018 Catalog Number :

Device Description : GEL-FLOW NT Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thr GEL-FLOW NT Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI, 5,000 International Units Syringe Spray Kit

Device Class : 3

Duns Number: 618054084

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

Prepidil® Gel, dinoprostone cervical gel - 00300093359017 Catalog Number :

Device Description : PREPIDIL Gel is available as a sterile semitranslucent viscous preparation for e PREPIDIL Gel is available as a sterile semitranslucent viscous preparation for endocervical application: 0.5 mg PGE2 per 3.0 g (2.5 mL) in syringe. In addition, each package contains two shielded catheters (10 mm and 20 mm tip) enclosed in sterile envelopes. The contents are not guaranteed sterile if envelopes are not intact.

Device Class :

Duns Number: 618054084

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

CLEOCIN® (clindamycin phosphate vaginal cream, USP), 7 day - 00300093448018 Catalog Number :

Device Description : Vaginal cream measuring applicator

Device Class : 1

Duns Number: 618054084

Premarket Exempt : No

Product Code : HGD

Prescription Use : Yes

Device Count : 1

CLEOCIN® (clindamycin phosphate vaginal suppositories) Vaginal Ovules - 00300097667019 Catalog Number :

Device Description : Vaginal ovule applicator

Device Class : 1

Duns Number: 618054084

Premarket Exempt : No

Product Code : HGD

Prescription Use : Yes

Device Count : 1

Clindamycin phosphate vaginal cream, USP, 7 day (Greenstone) - 00359762500915 Catalog Number :

Device Description : Vaginal cream measuring applicator

Device Class : 1

Duns Number: 618054084

Premarket Exempt : No

Product Code : HGD

Prescription Use : Yes

Device Count : 1

GELFOAM-JMI™ Sponge Kit - 00360793310107 Catalog Number :

Device Description : Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Sponge Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Sponge USP and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units)

Device Class : 3

Duns Number: 618054084

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

GELFOAM-JMI™ Powder Kit - 00360793410104 Catalog Number :

Device Description : Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Powder Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units)

Device Class : 3

Duns Number: 618054084

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

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