FDA.reportPublic FDA data

ELMED

Primary DI
00842180172395
Brand
ELMED
Company
ELMED INCORPORATED
Model
52001-00-6
Catalog number
52001-00-6
Device description
ELMED VALTCHEV UTERINE MOBILIZER SET: INCLUDES VALTCHEV UTERINE MOBILIZER, 2 CANNULAS OF DIFFENT SIZE & 4 OBTURATERS OF DIFFERENT SIZE
Published
2023-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180172395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180172395008421801723958421801723950842180172395

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19
00198506090912ELMED INCORPORATED35-6291435-629142026-05-19
00198506090929ELMED INCORPORATED33761-2133761-212026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
09349967004968Uterine ElevatOR PRO with OccludOR Balloon™THE O R COMPANY PTY LTDLKF2023-05-26
09349967004975Uterine ElevatOR PRO with OccludOR Balloon™THE O R COMPANY PTY LTDLKF2023-05-26
09349967004982Uterine ElevatOR PRO with OccludOR Balloon™THE O R COMPANY PTY LTDLKF2023-05-26
09349967005019Uterine ElevatOR PRO with OccludOR Balloon™THE O R COMPANY PTY LTDLKF2023-05-26
09349967005064Uterine ElevatOR PRO with Long Handle™THE O R COMPANY PTY LTDLKF2023-05-26
09349967005071Uterine ElevatOR PRO with Long Handle™THE O R COMPANY PTY LTDLKF2023-05-26
09349967005088Uterine ElevatOR PRO with Long Handle™THE O R COMPANY PTY LTDLKF2023-05-26
09349967005095Uterine ElevatOR PRO with Long Handle™THE O R COMPANY PTY LTDLKF2023-05-26
09349967005101Uterine PositionOR PRO™THE O R COMPANY PTY LTDLKF2023-05-26
09349967004890Occluder BalloonTHE O R COMPANY PTY LTDLKF2022-05-09
09349967003084Uterine PositionORTHE O R COMPANY PTY LTDLKF2022-02-24
09349967001028DUMI ManipulatORTHE O R COMPANY PTY LTDLKF2022-01-18
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
09349967000908Uterine ElevatOR PRO with Long HandleTHE O R COMPANY PTY LTDLKF2019-09-25
09349967000939Uterine ElevatOR PRO with Long HandleTHE O R COMPANY PTY LTDLKF2019-09-25
09349967000960Uterine ElevatOR PRO with Long HandleTHE O R COMPANY PTY LTDLKF2019-09-25
09349967000991Uterine ElevatOR PRO with Long HandleTHE O R COMPANY PTY LTDLKF2019-09-25
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30