FDA.reportPublic FDA data

EVONOS

Primary DI
00821925028197
Brand
EVONOS
Company
Gyrus ACMI, LLC
Model
130883
Device description
BLADE HANDLE, HEXAGONAL, #3HL, 15.5 CM
Published
2018-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
00821925028197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925028197008219250281978219250281970821925028197

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
007198742
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00198506090790ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-15
00198506090752ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
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00190776421366MillenniumAvalign Technologies, Inc.LRC2026-05-05
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00198506090387ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-30
00198506090394ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-30
00757770535620Bausch + LombBausch & Lomb IncorporatedLRC2026-04-30
00198506090318ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-28
00198506090257ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-21
00198506090288ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-21
00190776419950MillenniumAvalign Technologies, Inc.LRC2026-04-15
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00198506089954ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-03
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00198506089930ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
09348811172143INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-03-18
08904461031080OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
08904461055697OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00190776416218MillenniumAvalign Technologies, Inc.LRC2026-02-12