FDA.reportPublic FDA data

Poise

Primary DI
10036000470618
Brand
Poise
Company
KIMBERLY-CLARK GLOBAL SALES, INC.
Model
Pessary
Device description
POISE IMPRESSA SIZE 3 BLADDER SUPPORT DEVICE
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
10036000470618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1003600047061810036000470618

GMDN Terms#

Term, Definition table
TermDefinition
Urinary-incontinence vaginal insert, single-useA 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width50Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)340-3102xxx@xxx.xxx

Regulatory Flags#

DUNS number
829568273
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00036000586329U by KotexTampon; Pad2026-02-18
00036000596168U by KotexTampon; Pad2026-02-18
00036000597295U by KotexTampon; Pad2026-02-18
10036000563068U By KotexKOTEX TAMPONS2024-09-06
10036000373056U by KotexTampon2016-09-23
10036000426639U by KotexTampon2016-09-23
10036000426660U by KotexTampon2016-09-23
10036000448273U by KotexTampon2016-09-23
10036000472889U by KotexTampon2017-03-27
10036000475392U by KotexTampon2017-10-11
10036000475446U by KotexTampon2017-10-10
10036000477334U by KotexTampon2017-09-21
00036000151657U by KotexTampon2016-09-23
00036000157338U by KotexTampon2016-09-23
00036000159349U by KotexTampon2016-09-23
00036000373059U by KotexTampon2016-09-23
00036000423402U by KotexTampon2016-09-23
00036000426632U by KotexTampon2016-09-23
00036000426663U by KotexTampon2016-09-23
00036000435764U by KotexTampon2016-09-23

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