Duns Number:551540334
Device Description: Accessory boxContent:1. Box. AN1013292. Ear Tip PM009 9 mm mushroom. AN100767-P3. Ear Tip Accessory boxContent:1. Box. AN1013292. Ear Tip PM009 9 mm mushroom. AN100767-P3. Ear Tip PM010 10 mm mushroom. AN100768-P4. Ear Tip PM011 11 mm mushroom. AN100769-P5. Ear Tip PM012 12 mm mushroom. AN100770-P6. Ear Tip PM013 13 mm mushroom. AN100771-P7. Ear Tip PM014 14 mm mushroom. AN100772-P8. Ear Tip ET-21 18 mm mushroom. AN100577
Catalog Number
-
Brand Name
Accessory Box AB08
Version/Model Number
100734-P
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
3886c452-ee25-427b-8898-3a86a4cc1b70
Public Version Date
January 25, 2022
Public Version Number
1
DI Record Publish Date
January 17, 2022
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 |