Prepidil® Gel, dinoprostone cervical gel

Primary DI
00300093359017
Brand
Prepidil® Gel, dinoprostone cervical gel
Company
PHARMACIA & UPJOHN COMPANY LLC
Model
NDC 0009-3359-01
Device description
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.
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00300093359024PackageGS15In Commercial Distribution
00300093359017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00300093359024003000933590243000933590240300093359024
00300093359017003000933590173000933590170300093359017

GMDN Terms#

Term, Definition table
TermDefinition
Cervical dilatation catheterA flexible, tube-like device, typically with two or more inflatable balloons at the distal working end, designed to dilate (stretch open) the cervical canal after insertion through the cervical os and expansion of the balloons to assist in obstetrical or gynaecological procedures. It may be used for labour induction, spontaneously occurring labour, non-progressive labour, cervical dystocia, undesirable prolonged uterine contractions, and intrauterine foetal death (IUFD) where delivery of the foetus is difficult. Such procedures may be performed at or prior to full-term pregnancy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(484)865-6166UDICompliance@pfizer.com

Regulatory Flags#

DUNS number
618054084
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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10300090433045Gelfoam1 g Powder2014-09-01
00300090315085GelfoamSize 12-72014-09-01
00300090323011GelfoamSize 502014-09-01
00300090342012GelfoamSize 1002014-09-01
00300090349035GelfoamSize 2002014-09-01