Duns Number:106295384
Device Description: Lead Pulling Tip
Catalog Number
-
Brand Name
REF 7006 4-SITE ™ LEAD PULLING TIP
Version/Model Number
7006
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 2019
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
-
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
P910073,P910073
Product Code
NVY
Product Code Name
Permanent defibrillator electrodes
Public Device Record Key
611b02b9-dfed-464d-a185-33f5770b2378
Public Version Date
January 15, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2014
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 | 536 |
2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
3 | A medical device with high risk that requires premarket approval | 1821 |
U | Unclassified | 35 |