Duns Number:963383778
Device Description: Dual-Lead Cable Tray, Sterile
Catalog Number
80034
Brand Name
SPRINT
Version/Model Number
Dual-Lead Cable Tray, Sterile
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
NHI
Product Code Name
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Public Device Record Key
e6d6b33d-a782-4231-acd1-1567f858ee05
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
September 14, 2018
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. | 85 |