Duns Number:551540334
Device Description: Accessory boxContent:1. Transparent Lurex Box 11 compartments. AN1003362. Probe Tip 'Adult Accessory boxContent:1. Transparent Lurex Box 11 compartments. AN1003362. Probe Tip 'Adult' for Children & Adults. AN1000133. Ear tip ET-03 5 mm. AN1000634. Ear tip Lamella 6-10mm, blue. AN1000645. Ear Tip, Lamella 8-11mm. AN1001446. Ear tip ET-11 Lamella 12-16mm. AN1001257. EarTip Soft ET-16 10mm. AN1008388. Ear tip Soft ET-17 14 mm. AN1008399. Inspection tool. AN101326
Catalog Number
101327
Brand Name
1077 Accessory Box AB07
Version/Model Number
8-69-41350
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
K100661
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
7bbac510-59a7-48d6-b120-dc1cc405f56c
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 |