FDA.reportPublic FDA data

Bioteque Taiwan Ltd.

Primary DI
04719894430676
Brand
Bioteque Taiwan Ltd.
Company
Bioteque Taiwan Ltd.
Model
CPs2
Published
2024-12-06
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
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
04719894430676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719894430676047198944306764719894430676

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
657769858
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
04719894432328BiotequeM00152024-04-08
04719894432434BiotequeOS265BA-12024-04-08
04719894432441BiotequeOS265BA-22024-04-08
04719894432458BiotequeOS265BA-32024-04-08
04719894432571BiotequeBA05F2024-04-08
04719894432588BiotequeBA07F2024-04-08
04719894432595BiotequeBA051F2024-04-08
04719894432601BiotequeBA071F2024-04-08
04719894432618BiotequeBA05F-ST2024-04-08
04719894432625BiotequeBA0012024-04-08
04719894432755BiotequeUIC5F2024-04-08
04719894432762BiotequeUIC5FA2024-04-08
04719894432779BiotequeUIC5FAX2024-04-08
04719894432847BiotequeBA1002024-04-08
04719894432878BiotequeUMI4.52024-04-08
04719894432892BiotequeUMI4.5C2024-12-06
04719894432908BiotequeUMI4.5KC2024-12-06
04719894432915BiotequeUMI4.5K-G2024-12-06
04719894432922BiotequeUMI4.5-P2024-12-06
04719894432939BiotequeUI 4.02024-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850073946008EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946015EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946022EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946039EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946046EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946053EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946060EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946077EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946084EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946091EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946107EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946114EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946121EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946138EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946145EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946152EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946169EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946176EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946183EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946190EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946206EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946213EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946220EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946237EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946244EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946251EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946268EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946275EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946282EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946299EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14