FDA.reportPublic FDA data

Wallace

Primary DI
35019315015339
Brand
Wallace
Company
Smiths Medical International Ltd
Model
700/300/085
Published
2016-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
35019315015339PackageGS110Not in Commercial Distribution
55019315015333PackageGS1100Not in Commercial Distribution
15019315015335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931501533935019315015339
5501931501533355019315015333
1501931501533515019315015335

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic-organ-supporting pessaryA device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215591523
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30351688423256Portex008430M2015-09-01
30351688423270Portex008430T2015-09-01
30351688423287Portex008431T2015-09-01
30351688424277Portex0084352015-09-01
30351688404002Portex0020002016-10-05
35019517223334PortexC45101816D-NL2020-06-12
35019517236679PortexC45101817D-NL2020-09-18
30351688403036Portex0077672016-10-05
30351688410249Portex0022202016-12-28
30351688410355Portex0077602016-10-05
30351688416128Portex0022232016-12-28
30351688005896Portex5630902015-07-29
30351688018858Portex5630802015-07-29
30351688036715Portex5631002015-07-29
30351688041122Portex5260602015-07-29
30351688041139Portex5260702015-07-29
50351688041140Portex5260802015-07-29
30351688041153Portex5260902015-07-29
35019315052617Portex100/856/0752015-09-01
30351688415510Portex225-3524-8042016-10-11

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