FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506092749
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST513221
Catalog number
ST513221
Device description
Rochester Carmalt Hyst Forcep
Published
2026-07-28
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

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
00198506092749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506092749001985060927491985060927490198506092749

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842180179219ELMED569556952023-10-05
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18
00198506093883ELMED INCORPORATED9841FS-T9841FS-T2026-08-18
00198506093890ELMED INCORPORATED9831FS9831FS2026-08-18
00198506093906ELMED INCORPORATED9835FS9835FS2026-08-18
00198506093913ELMED INCORPORATED9843FS-T9843FS-T2026-08-18
00198506093920ELMED INCORPORATED9844FS-T9844FS-T2026-08-18
00198506093937ELMED INCORPORATEDSTE237820STE2378202026-08-18
00198506093944ELMED INCORPORATEDSTE322424ISTE322424I2026-08-18
00198506093951ELMED INCORPORATED31400-12353HD-OLY31400-12353HD-OLY2026-08-18
00198506093968ELMED INCORPORATED9846FS-T9846FS-T2026-08-18
00198506093975ELMED INCORPORATED25657-1025657-102026-08-18
00198506093982ELMED INCORPORATED22-5200-09F22-5200-09F2026-08-18
00198506093999ELMED INCORPORATEDSTE232825STE2328252026-08-18
00198506094002ELMED INCORPORATED24222-3824222-382026-08-18
00198506094019ELMED INCORPORATED9833FS9833FS2026-08-18
00198506094026ELMED INCORPORATED9842FS-T9842FS-T2026-08-18
00198506094033ELMED INCORPORATED9845FS-T9845FS-T2026-08-18
00198506094040ELMED INCORPORATED9837FS9837FS2026-08-18
00198506094057ELMED INCORPORATEDSTE3230124STE32301242026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092732ELMED 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
00198506072987ELMED 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