FDA.reportPublic FDA data

EVONOS

Primary DI
00821925024243
Brand
EVONOS
Company
Gyrus ACMI, LLC
Model
917606
Device description
EXCAVATOR RIGHT, SMALL, EBONY FINISH
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925024243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925024243008219250242438219250242430821925024243

GMDN Terms#

Term, Definition table
TermDefinition
Ear excavatorA hand-held manual surgical instrument designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear, allowing the performance of specialized procedures such as removal of the cochlear cupola and microsurgery of the middle ear and the sinus timpani. It is made of high-grade stainless steel and typically designed as a double-ended instrument having a central handle with small and sharp spoon-, scoop-, or spatula-shaped blades that have cutting/gouging edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
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
00821925032774Gyrus ACMI145011-ENT2016-09-29
00821925032859Gyrus ACMI145007-ENT2016-09-29
00821925032903Gyrus ACMI145216-ENT2016-09-29
00821925034044Gyrus ACMI2220-2210-052016-10-11
00821925034853Gyrus ACMI7089-08442018-09-13
00821925034860Gyrus ACMI7089-08462018-09-13
00821925034877Gyrus ACMI7089-08482018-09-13
00821925034884Gyrus ACMI7089-08502018-09-13
00821925034891Gyrus ACMI7089-08522018-09-13
00821925034907Gyrus ACMI7089-08542018-09-13
00821925034938Gyrus ACMI7089-08362018-09-13
00821925034945Gyrus ACMI7089-08382018-09-13
00821925034969Gyrus ACMI7089-08422018-09-13
00821925035072Gyrus ACMI145010-ENT2015-10-24
00821925036383Gyrus ACMIE-9F2016-10-13
00821925037915GYRUS ACMI004942-9012016-10-07
00821925037960Gyrus ACMI1010-2110-052016-10-07
00821925037977Gyrus ACMI1120-4110-052016-10-07
00821925038325Gyrus ACMICS-G52016-10-13
00821925038349Gyrus ACMIE-1F2016-10-13

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09348811172143INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-03-18
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