FDA.reportPublic FDA data

Uresta®

Primary DI
10692379000209
Brand
Uresta®
Company
Resilia Inc
Model
UR202
Catalog number
UR202
Device description
Uresta Bladder Support Size 2
Published
2020-11-23
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

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
10692379000209PackageGS112In Commercial Distribution
69237900020101PreviousGS10
00692379000202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069237900020910692379000209
6923790002010169237900020101
00692379000202006923790002026923790002020692379000202

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
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
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
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
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