FDA.reportPublic FDA data

MENIETT®

Primary DI
20885074415394
Brand
MENIETT®
Company
MEDTRONIC XOMED, INC.
Model
1010021044
Device description
EARPLUG 1010021044 12PK GREY 18MM
Published
2016-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETYTESTER, AUDITORY IMPEDANCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991562000PASCAL MEDICAL AB MENIETT 20Pascal Medical AB1999-12-28ETY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885074415394PackageGS112Not in Commercial Distribution
00885074415390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088507441539420885074415394
00885074415390008850744153908850744153900885074415390

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
12
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000032852Neuray®80040082019-03-17
00763000945817ApexCut EM187BL4012EM2026-10-24
00763000945824ApexCut EM187BL4040EM2026-10-24
00763000945831ApexCut EM187BL4060EM2026-10-24
00763000945848ApexCut EM187BL2975EM2026-10-24
00763000945855ApexCut EM187BL3590EM2026-10-24
00763000957858ApexCut EM187BL4000LEM2026-10-24
20763000089652SLIDE-ON® ENDOSHEATH®2245012018-07-07
00681490038997N/A13565012017-09-10
00681490040488NA14160002015-06-23
00681490040518NA14160302015-06-23
20681490040604N/A14190202017-10-13
20681490041762NA15140002016-04-30
20681490042424NA15325002015-06-25
20681490069315NA31185302016-04-17
20681490138622BRIDGEMASTER®6003022017-09-09
20681490138646BOOMERANG®6005002017-09-09
20643169232000Alar ™150002017-10-13
00643169553019XPS®1898200TLO2016-05-01
00643169564749VISAO®3334800LO2016-05-01

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