FDA.reportPublic FDA data

Doselogix

Primary DI
10813360022073
Brand
Doselogix
Company
TEAM TECHNOLOGIES, INC.
Model
TCPERL01
Catalog number
755013
Device description
TCPERL01-ROSEQUARTZ, 35ML, PERL VAGINAL DOSING SYSTEM
Published
2022-09-07
Public version status
New
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
10813360022073PackageGS125In Commercial Distribution
20813360022070PackageGS110In Commercial Distribution
00813360022076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002207310813360022073
2081336002207020813360022070
00813360022076008133600220768133600220760813360022076

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 Temperature35 Degrees Fahrenheit160 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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
00813360023233DoselogixTC5-A-BLUE7557452026-05-05
00813360023639DoselogixTC5-A-LSPR-3.5ML 6.5ML Micro7557752026-03-24
00813360023240DoselogixTC5-A-RED7557472025-06-05
00813360023257DoselogixTC5-A-BLUE7557482025-06-05
00813360023226DoselogixTC9-A-LIGHTSAFE-6.5ML ANGLED7557432025-05-12
00813360023189DoselogixTC35-CRTC35-CR-BLUE2025-08-01
00813360023196DoselogixTC35-CRTC35-CR-PINK2025-08-01
00813360023202DoselogixTC35-CRTC35-CR-GREY2025-08-01
00813360023219DoselogixTC35-CRTC35-CR-White2025-08-01
00813360023172DoselogixDOSE LOGIX TC5-A-RED 3.5ML7557412025-04-21
00813360023158DoselogixTC35-CHKTC35-CHK-BLUE2025-02-25
00813360023165DoselogixTC35-CHKTC35-CHK-PINK2025-02-25
00813360023554DoselogixTC9-A-BLUE 3.5ML Micro7556232024-08-13
00813360023561DoselogixTC9-A-BLUE 6.5ML Micro7556242024-08-13
00813360023578DoselogixTC9-A-LIGHTSAFE 3.5ML Micro7556252024-08-13
00813360023585DoselogixTC9-A-LIGHTSAFE 6.5ML Micro7556262024-08-13
00813360023592DoselogixTC9-R-BLUE 3.5ML Micro7556272024-08-13
00813360023608DoselogixTC9-R-BLUE 6.5ML Micro7556282024-08-13
00813360023615DoselogixTC9-R-LIGHTSAFE 3.5ML Micro7556292024-08-13
00813360023622DoselogixTC9-R-LIGHTSAFE 6.5ML Micro7556302024-08-13

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
00813360022069DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-01
00813360021994DoselogixTEAM TECHNOLOGIES, INC.HGD2022-07-30
08057509880031NAINGE SPAHGD2022-07-17
08057509880024NAINGE SPAHGD2022-07-17
00653160055733CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHGD2022-01-02