FDA.reportPublic FDA data

Premier

Primary DI
00348783015881
Brand
Premier
Company
Bioteque Taiwan Ltd.
Model
1040406
Published
2026-11-03
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
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
K092981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092981000PANPAC VAGINAL PESSARYPanpac Medical Corporation2010-07-22HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783015881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783015881003487830158813487830158810348783015881

Regulatory Flags#

DUNS number
657769858
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
00348783015829Premier10404002026-11-03
00348783015836Premier10404012026-11-03
00348783015843Premier10404022026-11-03
00348783015850Premier10404032026-11-03
00348783015867Premier10404042026-11-03
00348783015874Premier10404052026-11-03
00348783015898Premier10403002026-11-03
00348783015904Premier10403012026-11-03
00348783015911Premier10403022026-11-03
00348783015928Premier10403032026-11-03
00348783015935Premier10403042026-11-03
00348783015942Premier10403052026-11-03
00348783015959Premier10403062026-11-03
00348783015966Premier10402012026-11-03
00348783015973Premier10402022026-11-03
00348783015980Premier10402032026-11-03
00348783015997Premier10402042026-11-03
00348783016000Premier10402052026-11-03
00348783016017Premier10402062026-11-03
00348783016024Premier10402072026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783015829PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015836PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015843PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015850PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015867PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015874PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015898PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015904PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015911PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015928PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015935PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015942PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015959PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015966PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015973PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015980PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015997PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016000PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016017PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016024PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016031PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016123PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016130PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016147PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016154PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016161PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016178PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016185PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016192PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016055PremierBioteque Taiwan Ltd.HHW2026-09-02