FDA.reportPublic FDA data

LTL Medical

Primary DI
04719894436302
Brand
LTL Medical
Company
Bioteque Taiwan Ltd.
Model
R7
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
04719894436302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719894436302047198944363024719894436302

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
04719894435909LTL MedicalCUd22026-07-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894370811RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370897RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370903RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370910RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370927RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370934RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370941RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370958RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370965RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370972RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370989RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370996RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371009RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371016RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371023RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371030RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371047RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371054RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371061RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371078RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371085RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371092RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371108RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371115RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371122RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371139RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371146RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371153RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371160RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371177RELIEEVLI Medical Corporation LTHHW2026-08-23