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

GMDN Terms#

Term, Definition table
TermDefinition
Earplugs, single-useA device usually used as a pair made of rubber or pliable plastic/silicone material for insertion into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a single-use device.

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
00763000821777NIM EssenceNIMEID0602026-06-07
00763000821784NIM EssenceNIMEID0652026-06-07
00763000821791NIM EssenceNIMEID0702026-06-07
00763000821807NIM EssenceNIMEID0752026-06-07
00763000821814NIM EssenceNIMEID0802026-06-07
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12

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Primary DI, Brand, Company table
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08051597160099ResonanceM.R.S. SRLETY2025-09-01
04260223142994Sentiero Desktop DiagnosticPATH medical GmbHETY2024-05-22
05060488902673Amplivox AMPLIVOX LIMITEDETY2024-01-08
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05060488902680Amplivox AMPLIVOX LIMITEDETY2023-12-22
00732094082760Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
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00732094084733Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
05713315009396Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15