FDA.reportPublic FDA data

Reia

Primary DI
00860012119349
Brand
Reia
Company
Reia, LLC
Model
FP01-2
Device description
Size 2 Fitting 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
00860012119349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012119349008600121193498600121193490860012119349

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
00860012119301ReiaPP01-12024-07-22
00860012119318ReiaPP01-22024-07-22
00860012119325ReiaPP01-32024-07-22
00860012119332ReiaFP01-12024-07-22
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
04719894435893LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435909LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435916LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435923LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435930LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435947LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435954LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435961LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435978LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435985LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435992LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436005LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436012LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436029LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436036LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436043LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436050LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436067LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436074LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436081LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436098LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436104LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436111LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436128LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436135LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436142LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436159LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436166LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436173LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436180LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24