Duns Number:314101143
Device Description: Unshielded 3 Lead Miniclip AAMI 0.7m
Catalog Number
989803144941
Brand Name
NA
Version/Model Number
CBL Unshielded 3 Ld Miniclip AAMI 0.7m
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"
-
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
-
Product Code
IKD
Product Code Name
CABLE, ELECTRODE
Public Device Record Key
2a12532e-9ccd-47e9-b2b2-807494f823d8
Public Version Date
August 15, 2022
Public Version Number
5
DI Record Publish Date
November 10, 2016
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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 209 |