FDA.report

ELMED

Primary DI
00842180176546
Brand
ELMED
Company
ELMED INCORPORATED
Model
51-28260-H
Catalog number
51-28260-H
Device description
UTERINE SUCTION HANDLE
Published
2023-08-28
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

Related Records

Contact Domains

Product Codes

CodeName
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications

CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180176546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180176546008421801765468421801765460842180176546

GMDN Terms

TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, reusableA collection of various surgical instruments, dressings, and materials intended to be used during obstetrical/gynaecological surgery. It is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific type of surgical procedure; it does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23
00198506089695ELMED INCORPORATEDSM-T9931FS-AN-TSM-T9931FS-AN-T2026-03-20
00198506089701ELMED INCORPORATEDSTE5502610ASTE5502610A2026-03-20
00198506089718ELMED INCORPORATEDSTE235920STE2359202026-03-20
00198506089732ELMED INCORPORATEDSTESS572004DSTESS572004D2026-03-20
00198506089749ELMED INCORPORATEDSTESS571004DSTESS571004D2026-03-20
00198506055393ELMED INCORPORATEDSTF9911FSTF9911F2026-03-19
00198506089602ELMED INCORPORATED11126-1111126-112026-03-17
00198506089619ELMED INCORPORATEDSTE3610810600STE36108106002026-03-17
00198506089626ELMED INCORPORATED23-31-040223-31-04022026-03-17
00198506089633ELMED INCORPORATED40-652540-65252026-03-17
00198506089640ELMED INCORPORATED30670-2830670-282026-03-17
00198506089657ELMED INCORPORATED42-170042-17002026-03-17
00198506089664ELMED INCORPORATED38-1093-I38-1093-I2026-03-17
00198506089671ELMED INCORPORATED69127-0369127-032026-03-17
00198506089688ELMED INCORPORATED69127-0269127-022026-03-17
00198506089510ELMED INCORPORATEDSTE11510929STE115109292026-03-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
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
00840306835407Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835544Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835896Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835902Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836022Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836046Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836053Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00198506074264ELMED INCORPORATEDELMED INCORPORATEDLKF2025-01-15
00198506017858ELMED INCORPORATEDELMED INCORPORATEDLKF2025-01-10
04719894432977Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432984Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432991Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894433004Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
00198506017827ELMED INCORPORATEDELMED INCORPORATEDLKF2024-11-14
00859500005097FemChec FEMASYS INC.LKF2024-09-16
00840306830044Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830051Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830068Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830075Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06