FDA.reportPublic FDA data

evonos

Primary DI
04054462900282
Brand
evonos
Company
evonos GmbH & Co. KG
Model
WT000835
Catalog number
WT000835
Device description
Round knife, acc. to Rosen, angled 90, size 2.0
Published
2026-08-18
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
JYOKnife, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYOKnife, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054462900282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462900282040544629002824054462900282

GMDN Terms#

Term, Definition table
TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. 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
04054462910793evonosWT335401WT3354012026-08-19
04054462910823evonosWT335404WT3354042026-08-19
04054462910830evonosWT335405WT3354052026-08-19
04054462910847evonosWT335406WT3354062026-08-19
04054462910854evonosWT335409WT3354092026-08-19
04054462910861evonosWT335410WT3354102026-08-19
04054462910878evonosWT335413WT3354132026-08-19
04054462910885evonosWT335414WT3354142026-08-19
04054462910892evonosWT335500WT3355002026-08-19
04054462910908evonosWT335600WT3356002026-08-19
04054462910915evonosWT335800WT3358002026-08-19
04054462910922evonosWT335801WT3358012026-08-19
04054462910939evonosWT335802WT3358022026-08-19
04054462910953evonosWT335901WT3359012026-08-19
04054462910960evonosWT335902WT3359022026-08-19
04054462910991evonosWT336101WT3361012026-08-19
04054462911011evonosWT336202WT3362022026-08-19
04054462911028evonosWT336203WT3362032026-08-19
04054462911035evonosWT336204WT3362042026-08-19
04054462911042evonosWT336300WT3363002026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462901913evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901920evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901951evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901968evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906482evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906499evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906550evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906567evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906574evonosevonos GmbH & Co. KGJYO2026-08-18
04054462907533evonosevonos GmbH & Co. KGJYO2026-08-18
09348811109194INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811150257INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811109798INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-30
00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
00757770434268Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
20757770457568Bausch + LombBausch & Lomb IncorporatedJYO2026-04-30
20757770457551Bausch + LombBausch & Lomb IncorporatedJYO2026-04-29
09348811150233INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-04-10
09348811150134INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-03-16
00757770712281Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
00757770714056Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
09348811108906INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811149923INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150141INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150189INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150196INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811111746INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111753INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111760INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111777INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24