FDA.reportPublic FDA data

Uresta®

Primary DI
10692379000230
Brand
Uresta®
Company
Resilia Inc
Model
UR205
Catalog number
UR205
Device description
Uresta Bladder Support Size 5
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
10692379000230PackageGS112In Commercial Distribution
69237900023102PreviousGS10
00692379000233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069237900023010692379000230
6923790002310269237900023102
00692379000233006923790002336923790002330692379000233

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
00692379000172Uresta®RS000172RS0001722026-08-01
00692379000110Uresta®UR202BUR202B2026-08-01
00692379000127Uresta®UR203BUR203B2026-08-01
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
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
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