ProVate

Primary DI
27290019296113
Brand
ProVate
Company
CONTIPI MEDICAL LTD
Model
Size 85 Model DIT-Foster colorant
Device description
ProVate product size 85. 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
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

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
27290019296113PackageGS110In Commercial Distribution
17290019296116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729001929611327290019296113
1729001929611617290019296116

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
600087064
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
17290019296109ProVateSize 79 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
27290019296120ProVateSize 91 Model DIT-Foster colorant2024-10-30

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Primary DI, Brand, Company table
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