Duns Number:835465063
Device Description: WIRE 945DSE0005 1.2M48IN ASSORTED LEAD
Catalog Number
-
Brand Name
NA
Version/Model Number
945DSE0005
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
K061639,K061639
Product Code
GWE
Product Code Name
Stimulator, photic, evoked response
Public Device Record Key
8f3ea97b-8e6e-40e7-8e5f-ffa744504a71
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 08, 2016
Package DI Number
20613994330073
Quantity per Package
10
Contains DI Package
00613994330079
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |