FDA.reportPublic FDA data

Bioteque America, Inc.

Primary DI
00810142350686
Brand
Bioteque America, Inc.
Company
Bioteque America, Inc.
Model
CPs2
Device description
CUP PESSARY(w), CP 60/28S #2
Published
2025-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K013289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013289000BIOTEQUE VAGINAL PESSARIESBioteque America, Inc.2001-12-27HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810142350686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810142350686008101423506868101423506860810142350686

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
785179719
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
00810142350334Bioteque America, Inc.CUd22025-06-02
00810142352307Bioteque America, Inc.DT-B2025-05-30
00810142350587Bioteque America, Inc.CP02025-05-29
00810142350594Bioteque America, Inc.CP12025-05-29
00810142350600Bioteque America, Inc.CP22025-05-29
00810142350617Bioteque America, Inc.CP32025-05-29
00810142350624Bioteque America, Inc.CP42025-05-29
00810142350631Bioteque America, Inc.CP52025-05-29
00810142350648Bioteque America, Inc.CP62025-05-29
00810142350655Bioteque America, Inc.CP72025-05-29
00810142350662Bioteque America, Inc.CPs02025-05-29
00810142350679Bioteque America, Inc.CPs12025-05-29
00810142350693Bioteque America, Inc.CPs32025-05-29
00810142350709Bioteque America, Inc.CPs42025-05-29
00810142350716Bioteque America, Inc.CPs52025-05-29
00810142350723Bioteque America, Inc.CPs62025-05-29
00810142350730Bioteque America, Inc.CPs72025-05-29
00810142350754Bioteque America, Inc.DSH12025-05-29
00810142350761Bioteque America, Inc.DSH22025-05-29
00810142350778Bioteque America, Inc.DSH32025-05-29

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