FDA.reportPublic FDA data

Reia

Primary DI
00860012119301
Brand
Reia
Company
Reia, LLC
Model
PP01-1
Device description
Size 1 Patient Pessary
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K232677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232677000Reia pessaryReia, LLC2024-05-21HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012119301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012119301008600121193018600121193010860012119301

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
081063360
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012119394ReiaFP01-K2024-09-05
00860012119318ReiaPP01-22024-07-22
00860012119325ReiaPP01-32024-07-22
00860012119332ReiaFP01-12024-07-22
00860012119349ReiaFP01-22024-07-22
00860012119356ReiaFP01-32024-07-22
00860012119363ReiaAA01-12024-07-22
00860012119370ReiaAA01-22024-07-22
00860012119387ReiaAA01-32024-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894370811RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370897RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370903RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370910RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370927RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370934RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370941RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370958RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370965RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370972RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370989RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370996RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371009RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371016RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371023RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371030RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371047RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371054RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371061RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371078RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371085RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371092RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371108RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371115RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371122RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371139RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371146RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371153RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371160RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371177RELIEEVLI Medical Corporation LTHHW2026-08-23