Duns Number:006261481
Device Description: MAPPING TOOL 10650 LES TST DETECT 5P 18L
Catalog Number
-
Brand Name
DETECT®
Version/Model Number
10650
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2017
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
-
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
a4176db1-65b1-4380-874e-82116ce28c06
Public Version Date
October 26, 2022
Public Version Number
6
DI Record Publish Date
September 21, 2015
Package DI Number
20613994377894
Quantity per Package
5
Contains DI Package
00613994377890
Package Discontinue Date
November 30, 2017
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 |