FDA.reportPublic FDA data

ELMED

Primary DI
00198506001024
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST2524521
Catalog number
ST2524521
Device description
Heaney Needle Holder, Curved TC tip, 25,000 teeth per square inch, 8” Overall Length(20.3cm)
Published
2024-04-24
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
00198506001024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506001024001985060010241985060010240198506001024

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
00198506039072ELMED INCORPORATEDST5240905ST52409052026-07-17
00198506092107ELMED INCORPORATEDST233061ST2330612026-07-17
00198506092114ELMED INCORPORATEDST233064ST2330642026-07-17
00198506092121ELMED INCORPORATEDST233065ST2330652026-07-17
00198506092152ELMED INCORPORATEDST1976718ST19767182026-07-17
00198506092176ELMED INCORPORATEDST5220340ST52203402026-07-17
00198506092190ELMED INCORPORATEDST5243000HST5243000H2026-07-17
00198506092206ELMED INCORPORATEDST5243004HST5243004H2026-07-17
00198506092213ELMED INCORPORATEDST5243005HST5243005H2026-07-17
00198506092220ELMED INCORPORATEDST5246000HST5246000H2026-07-17
00198506092237ELMED INCORPORATEDST5246003HST5246003H2026-07-17
00198506092244ELMED INCORPORATEDST5246004HST5246004H2026-07-17
00198506092251ELMED INCORPORATEDST5246005HST5246005H2026-07-17
00198506092268ELMED INCORPORATEDST5246006HST5246006H2026-07-17
00198506092275ELMED INCORPORATEDST5240900ST52409002026-07-17
00198506092282ELMED INCORPORATEDST5240901ST52409012026-07-17
00198506092299ELMED INCORPORATEDST5240904ST52409042026-07-17
00198506092305ELMED INCORPORATEDST5241200ST52412002026-07-17
00198506092312ELMED INCORPORATEDST5241201ST52412012026-07-17
00198506092329ELMED INCORPORATEDST5241202ST52412022026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091865ELMED INCORPORATEDELMED INCORPORATEDHCF2026-07-10
05060411982963Birks Tying Forceps 110mm, 5mm Platform with 0.3mm TipsDTR MEDICAL LIMITEDHCF2026-06-10
05060411983021Crilewood Needle Holder 150mmDTR MEDICAL LIMITEDHCF2026-06-10
05060411984486De Bakey Needle Holder 180mmDTR MEDICAL LIMITEDHCF2026-06-10
05060411985032Castroviejo Needle Holder with Lock 145mmDTR MEDICAL LIMITEDHCF2026-06-10
05060411986961Barraquer Needle Holder 120mm, Curved 12mm Jaws, non lockingDTR MEDICAL LIMITEDHCF2026-06-10
00198506091285ELMED INCORPORATEDELMED INCORPORATEDHCF2026-06-09
00192896123441Barraquer Anis Needle HolderSONTEC INSTRUMENTS, INC.HCF2026-06-02
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
00198506085963ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-03
00198506072956ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
00198506082214ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02