FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506063473
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST21320
Catalog number
ST21320
Device description
No. 3KL blade handle. Round, knurled. Overall length 6in (15.2cm).
Published
2024-10-17
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
EMFKnife, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506063473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506063473001985060634731985060634730198506063473

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). 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
00198506085659ELMED INCORPORATEDELMED INCORPORATEDEMF2025-10-02
10888277370647MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-02-14
10888277377615MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-01-21
00860010523902VECTRRafael Medical Devices, LLCEMF2025-01-10
00842180160613ELMEDELMED INCORPORATEDEMF2023-01-30
00842180147737ELMEDELMED INCORPORATEDEMF2022-12-22
14026704810861PILLINGTELEFLEX INCORPORATEDEMF2022-12-08
00192896113701Cottle Mucosa KnifeSONTEC INSTRUMENTS, INC.EMF2022-09-15
00847399017239MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
00847399017246MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
10888277370623MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
10888277370630MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
00847399016003MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016010MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016034MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016935MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016942MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
20630140057523CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
20630140057530CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
00848782025527StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025541StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025572StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025602StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025633StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025657StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025671StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025688StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025763StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025787StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025831StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29