Duns Number:044611812
Device Description: 7FR SUTURE WING PKG
Catalog Number
6660014
Brand Name
Attachable Suture Wing
Version/Model Number
6660014
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
-
Product Code
KMK
Product Code Name
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Public Device Record Key
d482739e-ed25-4ef3-817e-48f50bf9347c
Public Version Date
September 30, 2022
Public Version Number
1
DI Record Publish Date
September 22, 2022
Package DI Number
10801741075138
Quantity per Package
10
Contains DI Package
00801741075131
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
U | Unclassified | 8 |