N/A

GUDID 00846430004542

4mm PVC ear tip 20pk

ETYMOTIC RESEARCH, INC.

Audiometric ear tip
Primary Device ID00846430004542
NIH Device Record Key07635222-f30f-48dd-99ab-29f41974fbcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberER3-14E
Company DUNS115380859
Company NameETYMOTIC RESEARCH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846430004542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [N/A]

00084643005257Jumbo foam eartip (3 pair)
00084643005240Small beige foam eartip (4 pair)
00084643005233Large 3-flange eartip (5 pair)
00084643005226Standard 3-flange (5 pair)
00846430005341Foam 13 mm (adult) ear tip 10/pk sample
00846430005310Electrode Cables (1pair)
00846430005280Hook and Loop Clips
00846430005273Sound delivery tube adapters (10/pk)
00846430005266Standard black foam eartip (5 pair)
00846430005211Various size eartips (156/pk)
0084643000520410mm foam ear tip 36pk
0084643000519813mm horn foam ear tip 36pk
00846430005075ER30 Earphone (pair), ER30-18 tubing with adapters, ER13-14 foam ear tips (13mm), ER13-14B foam
0084643000506810B+ Low Noise Microphone
00846430005051ER3C-50 Insert Earphone (pair) ER3-21 audiometric tubing, ER003452AR foam ear tips (13mm) ER0034
00846430005044ER3C-10 insert earphone (pair) ER3-21 audiometric tubing, ER003452AR foam ear tips (13mm), ER003
00846430005006ER30 Insert Earphones for Special Uses
00846430004993ER-3C Insert Earphone (50 ohm)
00846430004986ER3C-10 Insert Earphone for Audiometry (10 ohm)
00846430004849Impedance tip adapters with striped tubing (1 red, 1 blue)
00846430004801White tube nipples
0084643000479520' clear silicone tubing with tip adapters
00846430004788Tubing nipples
00846430004771right angle adapter
00846430004764Impedance tip adapters
00846430004757Impedance tip adapters
00846430004740Impedance tip adapters with tubing
00846430004733Impedance tip adapters
00846430004726Probe Tubes
00846430004719Probe Tubes
00846430004702Striped Sound Tubing
00846430004696Solid Color Silicone Sound Delivery Tubing with adapters
00846430004689Striped Sound Tubing 4pk
00846430004672Blue Striped Sound Tubing
00846430004665Striped Sound Tubing 4pk
00846430004658Striped Sound Tubing 500pk
00846430004641Striped SoundTubing 4pk
00846430004634Striped Red Tubing 100pk
00846430004610Tubephone coupling tubes 4pk
00846430004580Frost 3 flange ear tip (pair), 13mm black foam ear tip (pair), Clear 3 flange ear tip (pair), 10
00846430004573Infant silicone ear tip 100pk
008464300045664mm PVC ear tip 10pk
008464300045594mm PVC ear tip 14pk
008464300045424mm PVC ear tip 20pk
0084643000453518mm foam ear tip 4pk
0084643000452818mm foam ear tip 2pk
0084643000451118mm foam ear tip 24pk
008464300045043.5mm PVC ear tip 10pk
008464300044983.5mm PVC ear tip 14pk
008464300044813.5mm PVC ear tip 20pk

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