Duns Number:160020087
Device Description: 4mm Endoscopic Knife
Catalog Number
-
Brand Name
Endoscopic Scope-Mounting Blade
Version/Model Number
9900
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
NBH
Product Code Name
Accessories, Arthroscopic
Public Device Record Key
db18a7a8-704a-4cdf-9788-ac8a8e84a8e7
Public Version Date
January 23, 2020
Public Version Number
1
DI Record Publish Date
January 15, 2020
Package DI Number
10857915007504
Quantity per Package
5
Contains DI Package
00857915007507
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |