CNTRL+ Bladder Support Pessary

Primary DI
00990312419952
Brand
CNTRL+ Bladder Support Pessary
Company
Cntrl+ Inc.
Model
Starter Kit (S, M, L)
Catalog number
PES-0006
Device description
The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence). Starter Kit containing 3 devices: Small (GS1 #990312419945), Medium (GS1 #990312419969), Large (GS1 #990312419990). Each device is sold individually as well.
Published
2025-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHWPessary, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240798000Cntrl+ Bladder Support PessaryCntrl+, Inc.2024-12-17HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09903124199524PreviousGS10
00990312419952PrimaryGS10
00990312419976Unit of UseGS10
00999999999993Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
09903124199524099031241995249903124199524
00990312419952009903124199529903124199520990312419952
00990312419976009903124199769903124199760990312419976
00999999999993009999999999939999999999930999999999993

GMDN Terms#

Term, Definition table
TermDefinition
Bladder-supporting pessaryA non-sterile plastic device designed for insertion into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse. Otherwise known as a bladder-neck support prosthesis, it is designed in the form of a ring with two prongs at one end. The ring is intended to be placed and held in the vagina with the prongs projecting forwards on each side of the urethral opening, thereby supporting the urethra/bladder neck/bladder. This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height54.74Millimeter
Height59.24Millimeter
Height60.54Millimeter
Outer Diameter37.7Millimeter
Outer Diameter40.6Millimeter
Outer Diameter45.2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(855)268-7575support@cntrlplus.com

Regulatory Flags#

DUNS number
204238856
Device count
3
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00990312419945CNTRL+ Bladder Support PessarySmallPES-00032025-08-22
00990312419969CNTRL+ Bladder Support PessaryMediumPES-00042025-08-22
00990312419990CNTRL+ Bladder Support PessaryLargePES-00052025-08-22
09903124199524CNTRL+ Bladder Support PessaryStarter Kit (S, M, L)PES-00062026-02-22
09903124199456CNTRL+ Bladder Support PessarySmallPES-00032026-02-22
00999999999993CNTRL+ Bladder Support PessaryStarter Kit (S, M, L)PES-00062026-02-22
09903124199692CNTRL+ Bladder Support PessaryMediumPES-00042026-02-22
09903124199906CNTRL+ Bladder Support PessaryLargePES-00052026-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850073946008EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946015EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946022EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946039EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946046EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946053EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946060EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946077EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946084EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946091EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946107EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946114EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946121EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946138EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946145EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946152EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946169EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946176EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946183EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946190EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946206EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946213EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946220EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946237EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946244EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946251EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946268EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946275EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946282EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946299EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14