FDA.reportPublic FDA data

Wallace

Primary DI
15019315015304
Brand
Wallace
Company
ICU MEDICAL, INC.
Model
700/300/074
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
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
35019315015308PackageGS110Not in Commercial Distribution
55019315015302PackageGS1100Not in Commercial Distribution
15019315015304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931501530835019315015308
5501931501530255019315015302
1501931501530415019315015304

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.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

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