Duns Number:006261481
Device Description: CABLE 5833S 5PK SURG SM CLIP
Catalog Number
-
Brand Name
NA
Version/Model Number
5833S
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
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
K923407,K923407
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
4d42aec1-e555-4a7a-b012-f696c5ed4084
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 10, 2015
Package DI Number
10681490136355
Quantity per Package
5
Contains DI Package
00681490136358
Package Discontinue Date
-
Package Status
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 |