Duns Number:372587696
Device Description: Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture
Catalog Number
VR2218
Brand Name
VICRYL RAPIDE
Version/Model Number
VR2218
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
K033746,K033746
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
06a8cdfd-5bf2-452a-925a-cc2dc988a3a4
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
30705031225132
Quantity per Package
12
Contains DI Package
10705031225138
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 84 |