Duns Number:042075700
Device Description: The SuperClip is a sterile, single-use clip that can be used to secure drapes, guidewires The SuperClip is a sterile, single-use clip that can be used to secure drapes, guidewires or catheters during a vascular access or other cannulation procedure. Ridges on the ergonomically curved handle enables secure manipulation, and elastomeric pads provide a secure grip on drapes, wires, and catheters. The Model 4600-20 is yellow in color.
Catalog Number
140-0600-20
Brand Name
SuperClip Securement Clasp
Version/Model Number
4600-20
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"
Yes
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
KGZ
Product Code Name
Accessories, Catheter
Public Device Record Key
7120f40a-db63-4f86-b49a-35b536cabbf2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 30, 2017
Package DI Number
30815614020594
Quantity per Package
12
Contains DI Package
20815614020597
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |