FDA.reportPublic FDA data

Valtchev Uterine Mobilizer

Primary DI
00627843701804
Brand
Valtchev Uterine Mobilizer
Company
Conkin Surgical Instruments Ltd
Model
16A
Catalog number
16A
Device description
This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel cannula having a length of 83 mm and shaft thickness of 3 mm. The pin on the cannula must slip into the notch of the head of the VUM-6 base instrument. The cannula has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627843701804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627843701804006278437018046278437018040627843701804

GMDN Terms#

Term, Definition table
TermDefinition
Uterine elevatorA hand-held surgical instrument used to lift and manipulate the structure of the uterus to facilitate examination and surgery on this organ and/or the surrounding organs/tissue during a surgical intervention. It is typically a single-ended device with a blunted blade or hook with no cutting edges that can be of various shapes and a handle at the proximal end. It is usually made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length83Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
257261032
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628678764019Tray, Surgical Instrument ST-62023-06-26
00628678764002Tor-Mark Ocular Marker Tor-Mark-10 2023-03-02
00627843701781Valtchev Uterine MobilizerVUM-6VUM-62016-09-24
00627843701798Valtchev Uterine Mobilizer15A15A2016-09-24
00627843701811Valtchev Uterine Mobilizer17172016-09-24
00627843701828Valtchev Uterine Mobilizer18182016-09-24
00627843701835Valtchev Uterine Mobilizer19192016-09-24
00627843701842Valtchev Uterine Mobilizer20202016-09-24
00627843701859Valtchev Uterine MobilizerVTVT2016-09-24
00627843701866Valtchev Uterine Mobilizer9A9A2016-09-24
00627843701873Valtchev Uterine Mobilizer882016-09-24
10627843701788Valtchev Uterine MobilizerVUM-6VUM-62016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840306835360Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835377Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835384Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835391Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
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