FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506072987
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
75152-9994
Catalog number
75152-9994
Device description
"ZEPPELIN, HYST FORCEPS, ANGLED, CURVED, 9-1/2"""
Published
2025-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDEHook, Fibroid, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDEHook, Fibroid, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506072987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506072987001985060729871985060729870198506072987

GMDN Terms#

Term, Definition table
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 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
00198506092183ELMED INCORPORATEDST5352077ST53520772026-07-29
00198506092343ELMED INCORPORATEDST5501380MST5501380M2026-07-29
00198506092350ELMED INCORPORATEDST3510800800ST35108008002026-07-29
00198506092640ELMED INCORPORATEDSTST5250541STST52505412026-07-29
00198506093197ELMED INCORPORATEDST7511814ST75118142026-07-29
00198506093487ELMED INCORPORATEDST233985ST2339852026-07-29
00198506093494ELMED INCORPORATEDST231006TST231006T2026-07-29
00198506093500ELMED INCORPORATEDST234215SSST234215SS2026-07-29
00198506093517ELMED INCORPORATEDST235066ST2350662026-07-29
00198506093524ELMED INCORPORATEDST231875DST231875D2026-07-29
00198506093531ELMED INCORPORATEDST234558ST2345582026-07-29
00198506093548ELMED INCORPORATEDST235930ST2359302026-07-29
00198506093555ELMED INCORPORATEDST23742503ST237425032026-07-29
00198506093562ELMED INCORPORATEDST5250223ST52502232026-07-29
00198506093579ELMED INCORPORATEDSTF9932 FSTF9932 F2026-07-29
00198506093586ELMED INCORPORATEDST1109400ST11094002026-07-29
00198506093593ELMED INCORPORATEDST420958ST4209582026-07-29
00198506093609ELMED INCORPORATEDST3315705ST33157052026-07-29
00198506093616ELMED INCORPORATEDST3380118ST33801182026-07-29
00198506093630ELMED INCORPORATEDST3155NUTST3155NUT2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092732ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506092749ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506092831ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506093869ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506091667ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-10
00190776419271MillenniumAvalign Technologies, Inc.HDE2026-04-14
00190776414337MillenniumAvalign Technologies, Inc.HDE2025-10-23
00198506086069ELMED INCORPORATEDELMED INCORPORATEDHDE2025-10-08
00198506072895ELMED INCORPORATEDELMED INCORPORATEDHDE2025-10-02
00198506085819ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-25
00198506085833ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-25
00198506085680ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-18
00198506083235ELMED INCORPORATEDELMED INCORPORATEDHDE2025-05-29
00198506081156ELMED INCORPORATEDELMED INCORPORATEDHDE2025-03-10
G586OB6301180Novo SurgicalNOVO SURGICAL, INC.HDE2023-12-18
G586OB96301210Novo SurgicalNOVO SURGICAL, INC.HDE2023-12-18
00842331193538Novo Surgical Inc. NOVO SURGICAL, INC.HDE2023-12-07
00842331193545Novo Surgical Inc. NOVO SURGICAL, INC.HDE2023-12-07
00840319748350Hayden MedicalHayden Medical, Inc.HDE2023-03-21
00840319748367Hayden MedicalHayden Medical, Inc.HDE2023-03-21
14026704792280PILLINGTELEFLEX INCORPORATEDHDE2022-12-08
54026704792288PILLINGTELEFLEX INCORPORATEDHDE2022-12-08
00842331131370Novo Surgical Inc. NOVO SURGICAL, INC.HDE2022-11-10
00842331131417Novo Surgical Inc. NOVO SURGICAL, INC.HDE2022-11-10
00840306807305Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HDE2022-11-07
00887482074831Symmetry BuieASPEN SURGICAL PRODUCTS, INC.HDE2022-08-24
00190776041717AvalignAvalign Technologies, Inc.HDE2021-11-03
00190776211929AvalignAvalign Technologies, Inc.HDE2021-11-03
00190776176884MillenniumAvalign Technologies, Inc.HDE2021-11-01
00190776176891MillenniumAvalign Technologies, Inc.HDE2021-11-01