Duns Number:262783206
Device Description: Titanium Hemostatic Clip - Small/Medium Size
Catalog Number
L5180-1
Brand Name
SLS-CLIP
Version/Model Number
L5180-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 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
-
Product Code
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
584db2cf-cd0f-4b58-a7d3-7aefab4d64be
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 17, 2015
Package DI Number
03661624006389
Quantity per Package
48
Contains DI Package
03661624000127
Package Discontinue Date
June 01, 2016
Package Status
Not in Commercial Distribution
Package Type
grouping carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 18 |