Duns Number:551540334
Device Description: Accessory set including:1 pc. 100013 Probe Tip PT-A1 pc. 100219 Test Cavity for PT-A5pcs. Accessory set including:1 pc. 100013 Probe Tip PT-A1 pc. 100219 Test Cavity for PT-A5pcs. 100063 Ear Tip ET-035pcs. 100064 Ear Tip ET-105pcs. 100125 Ear Tip ET-115pcs. 100126 Ear Tip Soft ET-125pcs. 100144 Ear Tip ET-133pcs. 100230 Ear Tip Soft ET-141pc 100151 Cleaning Tool CT-01
Catalog Number
-
Brand Name
Accessory Box AB02
Version/Model Number
100207
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
a3b82a09-aa36-487c-bdc1-47d1e989096b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 02, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |