Duns Number:171843584
Device Description: PATTERSON DS18 4-0 CGUT 18"/45CM
Catalog Number
-
Brand Name
PATTERSON
Version/Model Number
089-9559
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
0fdce35c-1596-44a6-8026-b941201db1f3
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
D6620708995592
Quantity per Package
12
Contains DI Package
D6620708995590
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 145 |
U | Unclassified | 9 |