FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506085963
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
25230-23
Catalog number
25230-23
Device description
"MicroVascular Needle Holder, 23CM, 9"", TC"
Published
2025-10-03
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
HCFInstrument, Ligature Passing And Knot Tying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506085963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506085963001985060859631985060859630198506085963

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
00198506090653ELMED INCORPORATEDELMED INCORPORATEDHCF2026-05-12
00198506090486ELMED INCORPORATEDELMED INCORPORATEDHCF2026-05-05
14026704937131WECKTELEFLEX INCORPORATEDHCF2026-04-24
00840343727451Gen2SURGIX MEDICAL LLCHCF2026-04-22
04058749044812NAFehling Instruments GmbH & Co. KGHCF2026-04-22
00198506090035ELMED INCORPORATEDELMED INCORPORATEDHCF2026-04-08
00198506089893ELMED INCORPORATEDELMED INCORPORATEDHCF2026-04-02
04058749121087NAFehling Instruments GmbH & Co. KGHCF2026-03-05
00198506088223ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-27
00198506088162ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506088179ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-22
00198506087660ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00198506087776ELMED INCORPORATEDELMED INCORPORATEDHCF2026-01-16
00848657077989AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00848657077996AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HCF2026-01-13
00850012846512C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
10850012846519C1® DEPTH LIMITERLSI Solutions, Inc.HCF2025-12-08
04058749118711NAFehling Instruments GmbH & Co. KGHCF2025-12-08
00190776413446MillenniumAvalign Technologies, Inc.HCF2025-10-09
00198506072956ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082214ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082221ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
G453521053112M0PEAK MEDICALPeak Medical Distribution Inc.HCF2025-10-01
00190776411916MillenniumAvalign Technologies, Inc.HCF2025-09-25
00840217909952Wiggins medicalEbner Medical, LLCHCF2025-09-17
00198506085581ELMED INCORPORATEDELMED INCORPORATEDHCF2025-09-12
00198506085024ELMED INCORPORATEDELMED INCORPORATEDHCF2025-09-05
00198506084812ELMED INCORPORATEDELMED INCORPORATEDHCF2025-08-26
G4533352105310PEAK MEDICALPeak Medical Distribution Inc.HCF2025-08-13
00194613009137MSI Precision Specialty InstrumentsMed Saver, Inc.HCF2025-08-01