FDA.reportPublic FDA data

Aloe Cadabra

Primary DI
00826804005818
Brand
Aloe Cadabra
Company
SEVEN OAKS RANCH, INC.
Model
CHO2.5
Published
2023-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K124044000ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTSSeven Oaks Ranch, Inc.2013-08-30NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00826804005818PackageGS124In Commercial Distribution
00826804005788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00826804005818008268040058188268040058180826804005818
00826804005788008268040057888268040057880826804005788

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
090379004
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10826804004726Aloe CadabraBED2.92023-06-08
20826804001166Aloe CadabraCC2.52022-10-28
10826804004870Aloe CadabraGIN2.52022-10-28
10826804005662Aloe CadabraLEM2.52022-10-28
10826804000759Aloe CadabraPKS2.52022-10-01
10826804000810Aloe CadabraNA5.52022-10-01
10826804000872Aloe CadabraWAM.SA2022-08-22
20826804000190Aloe CadabraBC2.52019-06-16
20826804000206Aloe CadabraOC2.52019-06-16
20826804000213Aloe CadabraKL2.52019-06-16
10826804000025Aloe CadabraMAG2.52018-03-19
10826804006157Aloe CadabraVA2.52016-09-19
10826804006355Aloe CadabraPC2.52016-09-24
10826804006454Aloe CadabraMI2.52016-09-24
10826804106055Aloe CadabraNA.SA2016-10-07
10826804106253Aloe CadabraLA.SA2016-10-07
10826804106352Aloe CadabraPC.SA2016-10-03
10826804106451Aloe CadabraMI.SA2016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00796494455043LL Water-Based Gallon LubricantCC Wellness LLCNUC2026-05-28
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
20011509061328VagisilCombe IncorporatedNUC2026-01-26
00067981089127KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981089486KY Warming Jelly RB Health (us) LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRB Health (us) LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRB Health (us) LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
00016169700057Nauox Yin YangMAYER LABORATORIES, INC.NUC2025-10-06
00016169700064Nauox Holy HoneyMAYER LABORATORIES, INC.NUC2025-10-06
00016169700071Nauox Dulce DreamsMAYER LABORATORIES, INC.NUC2025-10-06
00016169700088Nauox Sweet HavenMAYER LABORATORIES, INC.NUC2025-10-06
00016169700095Naoux Agave NectarMAYER LABORATORIES, INC.NUC2025-10-06
00016169700194Femme GlydeMAYER LABORATORIES, INC.NUC2025-10-06
00198715811087Kindra V LubeMAYER LABORATORIES, INC.NUC2025-10-06
07964944077692LubeLife - Water-based 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
00067981993783K-Y® Hydrablend RB Health (us) LLCNUC2025-07-10
08032595872429REVAREEFARMA DERMA SRLNUC2025-06-26
08032595872436REVAREEFARMA DERMA SRLNUC2025-06-26
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHNUC2025-06-18
00067981994155KY Warming Liquid LubricantRB Health (us) LLCNUC2025-06-01
00067981994162KY Yours & Mine Couples LubricantRB Health (us) LLCNUC2025-06-01