Duns Number:027532357
Catalog Number
-
Brand Name
Burkhart 3-0 Chromic Suture 27", C-6 Needle
Version/Model Number
72720761
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
GAL
Product Code Name
Suture, Absorbable, Natural
Public Device Record Key
83695a42-ba29-4747-87c8-d4cdd5238080
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
March 03, 2016
Package DI Number
10854212006018
Quantity per Package
12
Contains DI Package
00854212006011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 214 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |