Duns Number:604056226
Device Description: Silicone Clamp Covers, Non-Sterile, Red, 0.14" (3.60mm) x 5"
Catalog Number
-
Brand Name
Key Surgical Silicone Clamp Covers
Version/Model Number
VS-201
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
61e2cf0c-c162-4e58-82c1-f1b36ccdfb1e
Public Version Date
September 08, 2021
Public Version Number
3
DI Record Publish Date
December 09, 2020
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 | 326 |
2 | A medical device with a moderate to high risk that requires special controls. | 219 |