FDA.reportPublic FDA data

EVONOS

Primary DI
00821925028401
Brand
EVONOS
Company
Gyrus ACMI, LLC
Model
231062
Device description
OSTEOTOME, TARDY RHINOPLASTY 2MM
Published
2018-09-11
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
00821925028401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925028401008219250284018219250284010821925028401

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a 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, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14250368820892Soft CliP HookHeinz Kurz GmbHLRC2026-05-21
14250368861437Trocar HandleHeinz Kurz GmbHLRC2026-05-21
14250368862007Cartilage PunchHeinz Kurz GmbHLRC2026-05-21
00198506090790ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-15
00198506090752ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
00198506090769ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
00190776421366MillenniumAvalign Technologies, Inc.LRC2026-05-05
00198506090479ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-05
00190776420758MillenniumAvalign Technologies, Inc.LRC2026-04-30
00190776420871MillenniumAvalign Technologies, Inc.LRC2026-04-30
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
00190776419578MillenniumAvalign Technologies, Inc.LRC2026-04-14
00190776419585MillenniumAvalign Technologies, Inc.LRC2026-04-14
00190776418977MillenniumAvalign Technologies, Inc.LRC2026-04-13
00198506089954ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-03
00198506089497ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089824ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089886ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089909ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
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