FDA.reportPublic FDA data

ELMED

Primary DI
00842180173781
Brand
ELMED
Company
ELMED INCORPORATED
Model
71712-09
Catalog number
71712-09
Device description
UTERINE CURETTE; SIMS, #3, 28CM
Published
2023-07-28
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
HCYCurette, Uterine
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180173781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180173781008421801737818421801737810842180173781

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, reusableA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800201Adler Instrument CompanyAdler, Inc.HNF2026-05-26
50198956419832CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-23
00192896122833Intraocular SetSONTEC INSTRUMENTS, INC.HNF2026-03-19
50198956405415CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-19
00198506089602ELMED INCORPORATEDELMED INCORPORATEDHNF2026-03-17
00192896122819Reynolds Tenotomy ScissorsSONTEC INSTRUMENTS, INC.HNF2026-03-10
50198956322415CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-06
50198956389852CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-02
50198956331509CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-23
50198956377156CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-23
50198956326857CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-17
50198956340679CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-13
50198956344646CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-13
50198956326635CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-09
50198956329513CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-09
50198956311907CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-30
50198956291926CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-26
50198956317428CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-26
50198956141665CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-07
50198956267587CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-07
50198956289589CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-05
50198956289329CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-29
50198956302240CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-26
00840319758366Hayden MedicalHayden Medical, Inc.HNF2025-12-24
00840319758373Hayden MedicalHayden Medical, Inc.HNF2025-12-24
50198956268225CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-22
50198956325249CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-22
50198956290080CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-19
04046826068424MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHCY2025-12-17
50198956252675CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-17