FDA.reportPublic FDA data

Doselogix

Primary DI
00813360022069
Brand
Doselogix
Company
Cordica Medical, Inc.
Model
TCPERL03
Catalog number
752647
Device description
DOSELOGIX TCPERL03 4.75ML PERL VAGINAL DOSING LOADER
Published
2022-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

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
10813360022066PackageGS125In Commercial Distribution
20813360022063PackageGS110In Commercial Distribution
00813360022069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002206610813360022066
2081336002206320813360022063
00813360022069008133600220698133600220690813360022069

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
078550672
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10813360023643UnoDoseUD45-WHITE-BULK504452026-10-20
10813360023674UnoDoseUD45-PURPLE-BULK504482026-10-20
10813360023681UnoDoseUD45-GREY-BULK504492026-10-20
20813360023640UnoDoseUD45-WHITE-BELMAR506152026-10-20
20813360023657UnoDoseUD45-GREEN-BULK504472026-10-20
20813360023671UnoDoseUD45-PURPLE-BELMAR506182026-10-20
20813360023688UnoDoseUD45-GREY-BELMAR506192026-10-20
30813360023647UnoDoseUD45-WHITE500002026-10-20
30813360023678UnoDoseUD45-PURPLE500032026-10-20
30813360023685UnoDoseUD45-GREY500042026-10-20
40813360023644UnoDoseUD45-WHITE-HALLANDALE506222026-10-20
10813360023667UnoDoseUD45-PINK-BULK504462026-10-06
20813360023664UnoDoseUD45-PINK-BELMAR506162026-10-06
30813360023661UnoDoseUD45-PINK500012026-10-06
00813360022076DoselogixTCPERL017550132022-09-07
00813360022083DoselogixTC35 White7551682022-09-07
00813360022106DoselogixTC35 Purple7551702022-09-07
00813360022113DoselogixTC35 Red7551712022-09-07
00813360022120DoselogixTC35 Black7551722022-09-07
00813360022137DoselogixTC35 Green7551732022-09-07

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
00813360022076DoselogixCordica Medical, Inc.HGD2022-09-07
10813360022073DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
00813360021994DoselogixCordica Medical, Inc.HGD2022-07-30
08057509880031NAINGE SPAHGD2022-07-17
08057509880024NAINGE SPAHGD2022-07-17
00653160055733CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHGD2022-01-02