FDA.reportPublic FDA data

Uresta®

Primary DI
69237900022006
Brand
Uresta®
Company
Resilia Inc
Model
UR204
Catalog number
UR204
Device description
Uresta Bladder Support Size 4
Published
2018-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
69237900022006PackageGS112In Commercial Distribution
69237900022105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6923790002200669237900022006
6923790002210569237900022105

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
1-866-560-5690krichard@resiliainc.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
00692379000110Uresta®UR202BUR202B2026-08-01
00692379000127Uresta®UR203BUR203B2026-08-01
00692379000134Uresta®UR204BUR204B2026-08-01
00692379000141Uresta®UR205BUR205B2026-08-01
00692379000158Uresta®UR206BUR206B2026-08-01
00692379000165Uresta®UR208BUR208B2026-08-01
00692379000172Uresta®RS00172RS001722026-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00692379000110Uresta®Resilia IncHHW2026-08-01
00692379000127Uresta®Resilia IncHHW2026-08-01
00692379000134Uresta®Resilia IncHHW2026-08-01
00692379000141Uresta®Resilia IncHHW2026-08-01
00692379000158Uresta®Resilia IncHHW2026-08-01
00692379000165Uresta®Resilia IncHHW2026-08-01
00692379000172Uresta®Resilia IncHHW2026-08-01
04719894435893LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435909LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435916LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435923LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435930LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435947LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435954LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435961LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435978LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435985LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435992LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436005LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436012LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436029LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436036LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436043LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436050LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436067LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436074LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436081LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436098LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436104LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436111LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24