Duns Number:800214827
Device Description: Patient lead wire for use with the Model 7A stimulator; black, left arm.
Catalog Number
8021
Brand Name
Model 7A
Version/Model Number
Left arm patient lead wire
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
-
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
P860008,P860008
Product Code
LPA
Product Code Name
System, Esophageal Pacing
Public Device Record Key
bece191c-652d-4c45-93d8-c77b587645ab
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 03, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 17 |