FDA.reportPublic FDA data

evonos

Primary DI
04054462904785
Brand
evonos
Company
evonos GmbH & Co. KG
Model
WT214016
Catalog number
WT214016
Device description
Needle holder, acc. to Mayo-Hegar, with tungsten carbide, size 160
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054462904785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462904785040544629047854054462904785

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

Regulatory Flags#

DUNS number
342657915
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
04054462156481evonosWT119400WT1194002026-08-26
04054462156498evonosWT524820WT5248202026-08-26
04054462156504evonosWT415000WT4150002026-08-26
04054462913039evonosWT415100WT4151002026-08-26
04054462913602evonosWT430432WT4304322026-08-25
04054462913619evonosWT430450WT4304502026-08-25
04054462913626evonosWT430452WT4304522026-08-25
04054462913633evonosWT432000WT4320002026-08-25
04054462913732evonosWT438512WT4385122026-08-25
04054462913763evonosWT438714WT4387142026-08-25
04054462913794evonosWT439000WT4390002026-08-25
04054462913824evonosWT439100WT4391002026-08-25
04054462913831evonosWT439200WT4392002026-08-25
04054462913855evonosWT440500WT4405002026-08-25
04054462913893evonosWT441500WT4415002026-08-25
04054462913909evonosWT442000WT4420002026-08-25
04054462913916evonosWT442100WT4421002026-08-25
04054462913923evonosWT442200WT4422002026-08-25
04054462913947evonosWT444000WT4440002026-08-25
04054462913978evonosWT445000WT4450002026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04058749001228NAFehling Instruments GmbH & Co. KGHXK2026-10-23
00190776436803MillenniumAvalign Technologies, Inc.HXK2026-10-21
00190776435097MillenniumAvalign Technologies, Inc.HXK2026-10-15
04058749027969NAFehling Instruments GmbH & Co. KGHXK2026-10-12
00190776432782MillenniumAvalign Technologies, Inc.HXK2026-09-29
00724995268916Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268923Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268930Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268947Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268954Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268961Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268978Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
04054462904747evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904754evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904761evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904778evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904792evonosevonos GmbH & Co. KGHXK2026-08-21
00850088713428PRINCETONPrinceton Medical Group, Inc.HXK2026-08-14
00840217910392Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910408Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910415Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910422Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910439Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910446Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910453Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910460Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910477Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910484Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
04058749047196NAFehling Instruments GmbH & Co. KGHXK2026-07-17
04058749117387NAFehling Instruments GmbH & Co. KGHXK2026-07-17