FDA.reportPublic FDA data

LTL Medical

Primary DI
04719894435909
Brand
LTL Medical
Company
Bioteque Taiwan Ltd.
Model
CUd2
Published
2026-07-24
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
04719894435909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719894435909047198944359094719894435909

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
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
00860011716853Monarch Medical ProductsMM1150A2026-07-24
00860011927617Monarch Medical ProductsMM012502026-07-24
00860011927662Monarch Medical ProductsMM00152026-07-24
00860011927686Monarch Medical ProductsMM010252026-07-24
04719894435893LTL MedicalCUd12026-07-24
04719894435916LTL MedicalCUd32026-07-24
04719894435923LTL MedicalCUd42026-07-24
04719894435930LTL MedicalCUd52026-07-24
04719894435947LTL MedicalCUd62026-07-24
04719894435954LTL MedicalCUd72026-07-24
04719894435961LTL MedicalD12026-07-24
04719894435978LTL MedicalD22026-07-24
04719894435985LTL MedicalD32026-07-24
04719894435992LTL MedicalD42026-07-24
04719894436005LTL MedicalD52026-07-24
04719894436012LTL MedicalD62026-07-24
04719894436029LTL MedicalDSHs12026-07-24
04719894436036LTL MedicalDSHs22026-07-24
04719894436043LTL MedicalDSHs32026-07-24
04719894436050LTL MedicalDSHs42026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894435893LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435916LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435923LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435930LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435947LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435954LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435961LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435978LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435985LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435992LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436005LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436012LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436029LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436036LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436043LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436050LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436067LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436074LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436081LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436098LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436104LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436111LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436128LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436135LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436142LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436159LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436166LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436173LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436180LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436197LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24