Duns Number:007883297
Device Description: #9-Semi-Sharp Hook, 90°, .5mm Tip, 230mm Length
Catalog Number
-
Brand Name
#9-Semi-Sharp Hook, 90°, .5mm Tip, 230mm Length
Version/Model Number
N7109E-K
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
-
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
GDG
Product Code Name
Hook, Surgical, General & Plastic Surgery
Public Device Record Key
177d0c4b-b78b-4b75-9b48-85d53769eb56
Public Version Date
June 25, 2020
Public Version Number
1
DI Record Publish Date
June 17, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1640 |
2 | A medical device with a moderate to high risk that requires special controls. | 288 |