FDA.reportPublic FDA data

CLEOCIN® (clindamycin phosphate vaginal suppositories) Vaginal Ovules

Primary DI
00300097667019
Brand
CLEOCIN® (clindamycin phosphate vaginal suppositories) Vaginal Ovules
Company
PHARMACIA & UPJOHN COMPANY LLC
Model
NDC 0009-7667-01
Device description
Vaginal ovule applicator
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGDAPPLICATOR, VAGINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGDApplicator, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00300097667019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00300097667019003000976670193000976670190300097667019

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal applicator, reusableA device designed to apply medication to the vagina. It is typically a hand-held bulb, pump, or injector used to introduce medicated powder or other substances into the vagina either directly or through an open speculum. It is typically used to treat vaginitis but can be used for other forms of vaginal treatment. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10300132647034Genotropin Pen® 12F0000991112019-09-05
10300134761929Genotropin Pen® 5F0001161532019-09-05
00300090297015GelfilmGelfilm® Sterile Ophthalmic Film Ophthalmic film 62015-10-22
10300090283015GelfilmGelfilm® Sterile Film Sterile film 1's (125 sq cm)2016-05-11
00300090283018GelfilmGelfilm® Sterile Film Sterile film 1's (125 sq cm)2015-10-22
00300091040016GEL-FLOW™ NTHemostatic Matrix for Flowable Applications - 6 mL2018-04-17
00300092250018GEL-FLOW KIT6 mL2018-08-17
00360793310107GELFOAM-JMI™ Sponge KitSize 1002017-06-05
00360793410104GELFOAM-JMI™ Powder Kit1 g Powder2017-06-05
10300090315082GelfoamSize 12-72014-09-01
10300090323018GelfoamSize 502014-09-01
10300090342019GelfoamSize 1002014-09-01
10300090349032GelfoamSize 2002014-09-01
10300090353015GelfoamSize 100 - Compressed2014-09-01
10300090396050GelfoamSize 4, 2 sponges per envelope2014-09-01
10300090433045Gelfoam1 g Powder2014-09-01
00300093359017Prepidil® Gel, dinoprostone cervical gelNDC 0009-3359-012020-09-24
00300090315085GelfoamSize 12-72014-09-01
00300090323011GelfoamSize 502014-09-01
00300090342012GelfoamSize 1002014-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015433701WandahCASCO BAY MOLDING LTD.HGD2026-05-15
00841445001388Diva Biome Balancer ApplicatorDiva International IncHGD2026-02-06
10378206189018XACIATOOrganon LLCHGD2024-09-13
00860012119363ReiaReia, LLCHGD2024-07-22
00860012119370ReiaReia, LLCHGD2024-07-22
00860012119387ReiaReia, LLCHGD2024-07-22
00850016867377Pixie CupPixie Cup LLCHGD2023-11-20
00850016867728Pixie CupPixie Cup LLCHGD2023-11-20
00719113275860Vaginal ApplicatorMai/GenesisHGD2023-09-14
00338779998410Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00338779998427Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00338779998434Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998417Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998424Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998431Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00860009492905VCA LitePce, Inc.HGD2023-08-11
00860009492912VCA LitePce, Inc.HGD2023-08-11
00826804000516Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804000523Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804000530Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006914Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006938Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006945Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006952Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00813360022076DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
10813360022073DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
00813360022069DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-01
00813360021994DoselogixTEAM TECHNOLOGIES, INC.HGD2022-07-30
08057509880031NAINGE SPAHGD2022-07-17
08057509880024NAINGE SPAHGD2022-07-17