Duns Number:812762226
Device Description: Stab Straight
Catalog Number
82-3001G
Brand Name
Stab Straight
Version/Model Number
82-3001G
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
K822112,K822112
Product Code
HNN
Product Code Name
Knife, ophthalmic
Public Device Record Key
2b11cb0d-5b7d-4754-ba70-70814c552e17
Public Version Date
February 07, 2020
Public Version Number
1
DI Record Publish Date
January 30, 2020
Package DI Number
10848782029911
Quantity per Package
5
Contains DI Package
00848782029914
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 | 300 |
2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
U | Unclassified | 19 |