FDA.reportPublic FDA data

ProVate

Primary DI
17290019296109
Brand
ProVate
Company
CONTIPI MEDICAL LTD
Model
Size 79 Model DIT-Foster colorant
Device description
ProVate product size 79. This device is single use only.
Published
2024-10-30
Public version status
New
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190277000ProVate Vaginal SupportContipi Medical , Ltd.2019-07-08HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290019296106PackageGS110In Commercial Distribution
17290019296109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729001929610627290019296106
1729001929610917290019296109

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
600087064
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290019296079ProVateSize 61 Model DIT-Foster colorant2024-10-30
17290019296086ProVateSize 67 Model DIT-Foster colorant2024-10-30
17290019296093ProVateSize 73 Model DIT-Foster colorant2024-10-30
17290019296116ProVateSize 85 Model DIT-Foster colorant2024-10-30
17290019296123ProVateSize 91 Model DIT-Foster colorant2024-10-30
27290019296076ProVateSize 61 Model DIT-Foster colorant2024-10-30
27290019296083ProVateSize 67 Model DIT-Foster colorant2024-10-30
27290019296090ProVateSize 73 Model DIT-Foster colorant2024-10-30
27290019296106ProVateSize 79 Model DIT-Foster colorant2024-10-30
27290019296113ProVateSize 85 Model DIT-Foster colorant2024-10-30
27290019296120ProVateSize 91 Model DIT-Foster colorant2024-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894432083BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432090BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432106BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432137BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432144BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432151BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432168BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432175BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432113BiotequeBioteque Taiwan Ltd.HHW2026-09-01
04719894432120BiotequeBioteque Taiwan Ltd.HHW2026-09-01
00810142350334Bioteque America, Inc.Bioteque America, Inc.HHW2025-06-02
00810142350587Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350594Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350600Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350617Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350624Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350631Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350648Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350655Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350662Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350679Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350686Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350693Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350709Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350716Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350723Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350730Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350754Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350761Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350778Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29