FDA.reportPublic FDA data

Uresta®

Primary DI
00692379000264
Brand
Uresta®
Company
Resilia Inc
Model
UR208
Catalog number
UR208
Device description
Uresta Bladder Support Starter Kit
Published
2020-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K081385000
K083769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081385000URESTA PESSARYEastmed, Inc.2008-10-09HHW
K083769000MODIFICATION TO URESTA PESSARYEastmed, Inc.2009-01-14HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10692379000261PackageGS16In Commercial Distribution
69237900025106PreviousGS10
00692379000264PrimaryGS10
00692379000257Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069237900026110692379000261
6923790002510669237900025106
00692379000264006923790002646923790002640692379000264
00692379000257006923790002576923790002570692379000257

GMDN Terms#

Term, Definition table
TermDefinition
Urinary-incontinence vaginal insert, reusableA non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). It is a non-absorbent device with a removal cord; an application kit (tube and push rod) is typically included. This is a reusable device - after appropriate cleaning - intended for single-patient use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-560-5690cchapman@resiliainc.com
1-866-560-5690support@uresta.com

Regulatory Flags#

DUNS number
202781183
Device count
3
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00692379000202Uresta®UR202UR2022020-11-23
00692379000219Uresta®UR203UR2032020-11-23
00692379000226Uresta®UR204UR2042020-11-23
00692379000233Uresta®UR205UR2052020-11-23
00692379000240Uresta®UR206UR2062020-11-23
10692379000209Uresta®UR202UR2022020-11-23
10692379000216Uresta®UR203UR2032020-11-23
10692379000223Uresta®UR204UR2042020-11-23
10692379000230Uresta®UR205UR2052020-11-23
10692379000247Uresta®UR206UR2062020-11-23
69237900020002Uresta®UR202UR2022018-05-23
69237900021009Uresta®UR203UR2032018-05-23
69237900022006Uresta®UR204UR2042018-05-23
69237900023003Uresta®UR205UR2052018-05-23
69237900024000Uresta®UR206UR2062018-05-23
69237900025007Uresta®UR208UR2082018-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09903124199524CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
04719894430003BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430010BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430034BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430584BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430591BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430904BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430911BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430928BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430935BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430942BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430959BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430966BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430973BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430980BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430997BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431000BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431017BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431024BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431031BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431048BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431055BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431062BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431079BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431086BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431093BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431109BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431116BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431123BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431130BiotequeBioteque Taiwan Ltd.HHW2024-12-06