FDA.reportPublic FDA data

evonos

Primary DI
04054462908042
Brand
evonos
Company
evonos GmbH & Co. KG
Model
WT269410
Catalog number
WT269410
Device description
Cutting jig, acc. to Fisch, for stapes prostheses, size 0.4 / 0.6
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
NNRBlock, Cutting, Ent, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNRBlock, Cutting, Ent, Non-SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054462908042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462908042040544629080424054462908042

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
04054462908035evonosevonos GmbH & Co. KGNNR2026-08-21
04054462908066evonosevonos GmbH & Co. KGNNR2026-08-21
04054462996810evonosevonos GmbH & Co. KGNNR2026-08-21
00810207784487Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDNNR2026-06-30
00190776421793MillenniumAvalign Technologies, Inc.NNR2026-06-24
04250676741882Cutting blockSpiggle & Theis Medizintechnik GmbHNNR2025-09-25
00190776407810MillenniumAvalign Technologies, Inc.NNR2025-08-01
00194613022167MSI Precision Specialty InstrumentsMed Saver, Inc.NNR2025-03-21
00194613030223MSI Precision Specialty InstrumentsMed Saver, Inc.NNR2025-03-21
00887482040379Symmetry TeflonASPEN SURGICAL PRODUCTS, INC.NNR2024-09-09
G043670000BEARBear-Ent, LLCNNR2024-08-15
00840183503512BR Surgical, LLCBR Surgical, LLCNNR2024-07-22
00840183527396BR Surgical, LLCBR Surgical, LLCNNR2024-07-22
00840306827525Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827532Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827549Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827556Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00190776293307MILLENNIUMAvalign Technologies, Inc.NNR2023-09-28
00190776320874MILLENNIUMAvalign Technologies, Inc.NNR2023-09-28
00840319753132Hayden MedicalHayden Medical, Inc.NNR2023-05-26
00842962145807HNM MEDICALHNM STAINLESS, LLC.NNR2023-04-03
14026704805690PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
54026704805698PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
14026704805683PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
00840306806865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-10
00840306806889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-10
00842331134210Novo Surgical Inc. NOVO SURGICAL, INC.NNR2022-11-10
00840306806872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-08
04250374712269Cutting block, glassSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250381850169Preparation tray, stainless steelSpiggle & Theis Medizintechnik GmbHNNR2022-09-14