Duns Number:006261481
Device Description: MAPPING TOOL 10650 LES TST DETECT 5P 26L
Catalog Number
-
Brand Name
DETECT®
Version/Model Number
10650
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 09, 2016
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
K040812,K040812
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
e5c0a0ea-dd20-4dd3-8e92-1fd854e3d9e6
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
June 23, 2015
Package DI Number
20613994755623
Quantity per Package
5
Contains DI Package
00613994755629
Package Discontinue Date
August 09, 2016
Package Status
Not 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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |