FDA.reportPublic FDA data

evonos

Primary DI
04054462912087
Brand
evonos
Company
evonos GmbH & Co. KG
Model
WT406012
Catalog number
WT406012
Device description
Osteotome, acc. to Rubin, with stabilizer, size 12 x 160
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
GFIOsteotome, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054462912087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462912087040544629120874054462912087

GMDN Terms#

Term, Definition table
TermDefinition
Nasal chiselA single-bladed, surgical instrument, bevelled on one side that is used to cut and shape the nasal bones during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design. It is typically a one-piece instrument 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
04054462912070evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912094evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912216evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912223evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912254evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912261evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912421evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912520evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912940evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912957evonosevonos GmbH & Co. KGGFI2026-08-19
04054462900305evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900312evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900329evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900336evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900343evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900350evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900367evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912100evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912131evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912148evonosevonos GmbH & Co. KGGFI2026-08-18
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