FDA.reportPublic FDA data

Grason & Associates, LLC

Primary DI
10840162500416
Brand
Grason & Associates, LLC
Company
Grason & Associates LLC
Model
PM018
Device description
Single use eartips, Bag of 100, PM018
Published
2022-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ETTCushion, Earphone (For Audiometric Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETTCushion, Earphone (For Audiometric Testing)Ear, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840162500416PrimaryGS10
00840162500419Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084016250041610840162500416
00840162500419008401625004198401625004190840162500419

GMDN Terms#

Term, Definition table
TermDefinition
Earphone cushionA device that is part of an earphone, sometimes detachable, which rests against the ear or head. In the case of audiometric ear phones the cushion is part of the specification for calibration purposes.

Regulatory Flags#

DUNS number
555553440
Device count
100
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840162500600Grason & Associates, LLCEC0512022-12-07
00840162500617Grason & Associates, LLCEC0522022-12-07
00840162500624Grason & Associates, LLCEC0532022-12-07
00840162500631Grason & Associates, LLCEC0542022-12-07
00840162501430Grason & Associates, LLC1007342022-12-07
00840162501447Grason & Associates, LLCEC0612022-12-07
00840162501454Grason & Associates, LLCEC0642022-12-07
10840162500317Grason & Associates, LLCPM0062022-11-11
10840162500324Grason & Associates, LLCPM0072022-11-11
10840162500331Grason & Associates, LLCPM0082022-11-11
10840162500348Grason & Associates, LLCPM0092022-11-11
10840162500355Grason & Associates, LLCPM0102022-11-11
10840162500362Grason & Associates, LLCPM0112022-11-11
10840162500379Grason & Associates, LLCPM0122022-11-11
10840162500386Grason & Associates, LLCPM0132022-11-11
10840162500393Grason & Associates, LLCPM0142022-11-11
10840162500409Grason & Associates, LLCPM0162022-11-11
10840162500423Grason & Associates, LLCPM1052022-11-11
10840162500430Grason & Associates, LLCPM1072022-11-11
10840162500447Grason & Associates, LLCPM1112022-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223146589Ear Tip ET-LT40G Pack/100 pcs.PATH medical GmbHETT2023-11-14
04260223146602Ear Tip ET-LT45G Pack/100 pcs.PATH medical GmbHETT2023-11-14
04260223146626Ear Tip ET-LT50G Pack/100 pcs.PATH medical GmbHETT2023-11-14
10840162500317Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500324Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500331Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500348Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500355Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500362Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500379Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500386Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500393Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500409Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500423Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500430Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500447Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500775Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500782Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500799Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500805Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500812Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500829Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500836Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500843Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500850Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500867Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500874Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500164Grason & Associates, LLCGrason & Associates LLCETT2022-11-10
10840162500171Grason & Associates, LLCGrason & Associates LLCETT2022-11-10
10840162500188Grason & Associates, LLCGrason & Associates LLCETT2022-11-10