FDA.reportPublic FDA data

EVONOS

Primary DI
00821925028418
Brand
EVONOS
Company
Gyrus ACMI, LLC
Model
231076
Device description
VIENNA NASAL SPECULA, MEDIUM
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
00821925028418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925028418008219250284188219250284180821925028418

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. 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
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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