FDA.reportPublic FDA data

EVONOS

Primary DI
00821925016033
Brand
EVONOS
Company
Gyrus ACMI, LLC
Model
130882
Device description
"HEXAGONAL BLADE HANDLE # 3H 3.9"" (10 CM) LONG"
Published
2018-09-10
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
00821925016033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925016033008219250160338219250160330821925016033

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgery mirrorA reflective device designed to be used to assist practitioners during general/plastic surgery by displaying the image of an object placed before it.

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
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435417MillenniumAvalign Technologies, Inc.LRC2026-10-19
00190776434946MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434977MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434618MillenniumAvalign Technologies, Inc.LRC2026-10-09
00198506095795ELMED INCORPORATEDELMED INCORPORATEDLRC2026-10-09
00190776433529MillenniumAvalign Technologies, Inc.LRC2026-10-06
00192896123854Gum ScissorsSONTEC INSTRUMENTS, INC.LRC2026-10-06
00190776433093MillenniumAvalign Technologies, Inc.LRC2026-10-01
00190776432539MillenniumAvalign Technologies, Inc.LRC2026-09-28
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776432270MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776431440MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776432140MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776428020MillenniumAvalign Technologies, Inc.LRC2026-08-27
00190776428174MillenniumAvalign Technologies, Inc.LRC2026-08-27
00844505014762BONE WAX APPLICATORGrace Medical, Inc.LRC2026-08-27
00190776427566MillenniumAvalign Technologies, Inc.LRC2026-08-26
04054462913633evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913732evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913763evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913794evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913824evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913831evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913855evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913893evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914005evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914012evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914036evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914067evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914074evonosevonos GmbH & Co. KGLRC2026-08-25