FDA.reportPublic FDA data

Bioteque America, Inc.

Primary DI
00810142352109
Brand
Bioteque America, Inc.
Company
Bioteque America, Inc.
Model
FS2000
Device description
FITTING SET WITH CUBE PESSARY
Published
2025-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00810142352109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810142352109008101423521098101423521090810142352109

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
785179719
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810142352093Bioteque America, Inc.FS10002025-05-29
00810142352116Bioteque America, Inc.FS30002025-05-29
00810142352123Bioteque America, Inc.FS40002025-05-29
00810142352130Bioteque America, Inc.FS50002025-05-29
00810142352147Bioteque America, Inc.FS60002025-05-29
00810142352154Bioteque America, Inc.FS70002025-05-29
00810142352161Bioteque America, Inc.FS80002025-05-29
00810142352178Bioteque America, Inc.FS90002025-05-29
00810142352185Bioteque America, Inc.FS11002025-05-29
00810142353373Bioteque America, Inc.FS99002025-05-29
00810142352192Bioteque America, Inc.PRM22025-05-23
00810142352338Bioteque America, Inc.BA82002025-05-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783016055PremierBioteque Taiwan Ltd.HHW2026-09-02
00348783016109PremierBioteque Taiwan Ltd.HHW2026-09-02
00348783016116PremierBioteque Taiwan Ltd.HHW2026-09-02
00348783016215PremierBioteque Taiwan Ltd.HHW2026-09-02
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
00348783016062PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016079PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016086PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016093PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016208PremierBioteque Taiwan Ltd.HHW2026-09-01
00348783016048PremierBioteque Taiwan Ltd.HHW2026-09-01
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