Duns Number:808865125
Catalog Number
LP7593G
Brand Name
SURGISTAR
Version/Model Number
885567
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
EMF
Product Code Name
Knife, Surgical
Public Device Record Key
88fdb5d7-81ec-4b10-bd13-4dea0ffc6116
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
July 29, 2016
Package DI Number
10878799009262
Quantity per Package
6
Contains DI Package
00878799009265
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 | 757 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 6 |