FDA.reportPublic FDA data

Grason & Associates, LLC

Primary DI
00840162500532
Brand
Grason & Associates, LLC
Company
Grason & Associates LLC
Model
GS013
Device description
Single use eartips, Bag of 100, GS013
Published
2022-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10840162500539PrimaryGS10
00840162500532Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084016250053910840162500539
00840162500532008401625005328401625005320840162500532

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
555553440
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10840162500416Grason & Associates, LLCPM0182022-11-11
10840162500423Grason & Associates, LLCPM1052022-11-11
10840162500430Grason & Associates, LLCPM1072022-11-11

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
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
10840162500416Grason & 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