FDA.reportPublic FDA data

Bioteque Taiwan Ltd.

Primary DI
04719894432991
Brand
Bioteque Taiwan Ltd.
Company
Bioteque Taiwan Ltd.
Model
UMI4.5K-G
Published
2024-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092980000PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5Panpac Medical Corporation2010-03-11LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719894432991PackageGS112In Commercial Distribution
04719894432915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719894432991047198944329914719894432991
04719894432915047198944329154719894432915

GMDN Terms#

Term, Definition table
TermDefinition
Uterine manipulator, single-useA sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00860011716853Monarch Medical ProductsBioteque Taiwan Ltd.LKF2026-07-24
04719894436456LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
04719894436463LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
04719894436470LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
M803003276512Uterine ManipulatorMEDGYN PRODUCTS, INC.LKF2026-06-08
M803003276515Uterine ManipulatorMEDGYN PRODUCTS, INC.LKF2026-06-08
00850011427378Titus Medical LLCTITUS MEDICAL LLCLKF2026-04-20
00850011427385TITUS MEDICALTITUS MEDICAL LLCLKF2026-04-19
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00888937029697ALLY II UPS (Uterine Positioning System)Coopersurgical, Inc.LKF2025-12-18
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
00198506017704ELMED INCORPORATEDELMED INCORPORATEDLKF2025-07-08
00860010540930Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
10860010540937Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
04719894432892BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432908BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432915BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432922BiotequeBioteque Taiwan Ltd.LKF2024-12-06
00840306826177Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
00840306826184Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
04719894432571BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432588BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432595BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432601BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432618BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432625BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432755BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432762BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432779BiotequeBioteque Taiwan Ltd.LKF2024-04-08