FDA.reportPublic FDA data

Uresta®

Primary DI
00692379000127
Brand
Uresta®
Company
Resilia Inc
Model
UR203B
Catalog number
UR203B
Device description
Uresta Bladder Support Size 3
Published
2026-08-01
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
false

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
K233548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233548000Uresta®Resilia, Inc.2024-04-03HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10692379000124PackageGS112In Commercial Distribution
00692379000127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069237900012410692379000124
00692379000127006923790001276923790001270692379000127

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.

Contacts#

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

Regulatory Flags#

DUNS number
202781183
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
true
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
00692379000172Uresta®RS000172RS0001722026-08-01
00692379000110Uresta®UR202BUR202B2026-08-01
00692379000134Uresta®UR204BUR204B2026-08-01
00692379000141Uresta®UR205BUR205B2026-08-01
00692379000158Uresta®UR206BUR206B2026-08-01
00692379000165Uresta®UR208BUR208B2026-08-01
00692379000097Water-based Lubricant for UrestaLU00097LU000972026-07-03
00692379000202Uresta®UR202UR2022020-11-23
00692379000219Uresta®UR203UR2032020-11-23
00692379000226Uresta®UR204UR2042020-11-23
00692379000233Uresta®UR205UR2052020-11-23
00692379000240Uresta®UR206UR2062020-11-23
00692379000264Uresta®UR208UR2082020-11-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894432083BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432090BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432106BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432137BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432144BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432151BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432168BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432175BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432113BiotequeBioteque Taiwan Ltd.HHW2026-09-01
04719894432120BiotequeBioteque Taiwan Ltd.HHW2026-09-01
00810142350334Bioteque America, Inc.Bioteque America, Inc.HHW2025-06-02
00810142350587Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350594Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350600Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350617Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350624Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350631Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350648Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350655Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350662Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350679Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350686Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350693Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350709Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350716Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350723Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350730Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350754Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350761Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350778Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29