FDA.reportPublic FDA data

Centurion

Primary DI
10653160243342
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
10FRGEL8
Catalog number
10FRGEL8
Device description
APPLICATOR; VAGINAL, 10FR, 8 1/2', STER.
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00653160243345PackageGS150In Commercial Distribution
10653160243342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160243345006531602433456531602433450653160243345
1065316024334210653160243342

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal applicator, single-useA device designed to apply medication to the vagina. It is typically a simple rod, blade, spatula, or paddle. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393511CENTURIONCIT4525ACIT4525A2026-07-28
10653160394068CENTURIONSUT11035ASUT11035A2026-07-21
10653160239369CENTURIONCHT805CHT8052022-01-01
10653160243694CENTURIONSUT17770SUT177702022-01-02
10653160277859CENTURIONSUT19145SUT191452022-01-02
10653160283966CENTURIONCVI4145CVI41452017-08-14
10653160285267CENTURIONMNS9625MNS96252022-01-02
10653160317937CENTURIONTRI66800TRI668002022-01-02
10653160322948CENTURIONSUT20915SUT209152022-01-02
10653160330783CENTURIONSUT21230ASUT21230A2022-01-02
10653160333883CENTURIONSUT18765ASUT18765A2022-01-02
10653160345220CENTURIONMNS13075MNS130752022-01-01
10653160360247CENTURIONMNS7285AMNS7285A2023-05-22
10653160374183CENTURIONMNS11780BMNS11780B2024-05-02
00653160013641CENTURIONMNS1080MNS10802022-01-01
00653160017762CENTURIONUVT235UVT2352022-01-02
00653160191349CENTURIONMNS5555MNS55552022-01-01
00653160199352CENTURIONSUT1243ASUT1243A2022-01-02
00653160200867CENTURIONSUT15260SUT152602022-01-02
00653160228397CENTURIONSUT17155SUT171552022-01-02

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