FDA.reportPublic FDA data

VCA Lite

Primary DI
00860009492912
Brand
VCA Lite
Company
Pce, Inc.
Model
Q033-G00-02
Device description
5.3 cc Vaginal Cream Applicator 3-Pack. Three applicators are packaged in a canister.
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
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
00860009492912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009492912008600094929128600094929120860009492912

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
876375916
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00860009492905VCA LiteQ033-G00-012023-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00826804000516Aloe CadabraSEVEN OAKS RANCH, INC.HGD2023-06-16
00826804000523Aloe CadabraSEVEN OAKS RANCH, INC.HGD2023-06-16
00826804000530Aloe CadabraSEVEN OAKS RANCH, INC.HGD2023-06-16
00826804006914Aloe CadabraSEVEN OAKS RANCH, INC.HGD2023-06-16
00826804006938Aloe CadabraSEVEN OAKS RANCH, INC.HGD2023-06-16
00826804006945Aloe CadabraSEVEN OAKS RANCH, INC.HGD2023-06-16
00826804006952Aloe CadabraSEVEN OAKS RANCH, INC.HGD2023-06-16
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
50653160055738CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHGD2022-01-02
00653160243345CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHGD2022-01-01
00850325006320Sephure® suppository applicatorCristcot LLCHGD2021-09-28
40193489342971Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HGD2021-08-27
00860004725107RipelicatorHuck Medical Technologies, Inc.HGD2021-07-28
20025715693150Ezy DoseAPOTHECARY PRODUCTS, LLCHGD2020-10-28