Duns Number:551540334
Device Description: Accessory Set including:5pcs. 101014 Probe Tip PT-LT1pc. 100160 Test Cavity PT-S20pcs. 101 Accessory Set including:5pcs. 101014 Probe Tip PT-LT1pc. 100160 Test Cavity PT-S20pcs. 101035 Ear Tip Soft ET-LT10F20pcs. 101036 Ear Tip Soft ET-LT14F20pcs. 101037 Ear Tip ET-LT3520pcs. 101038 Ear Tip ET-LT4020pcs. 101311 Ear Tip ET-LT8T20pcs. 101312 Ear Tip ET-LT13T3pcs. 100186 Filter disk1pc. 100151 Cleaning Tool CT-01
Catalog Number
-
Brand Name
Accessory box AB-LT01
Version/Model Number
101043
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
805c3fac-08b0-46e0-a384-de603bd256b4
Public Version Date
January 14, 2022
Public Version Number
2
DI Record Publish Date
April 14, 2020
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 |