Duns Number:315018218
Device Description: LANDOLT-REULEN TREND Pituitary Hook, 10 1/2", (265 mm), working length: , 5 1/2", (140 mm) LANDOLT-REULEN TREND Pituitary Hook, 10 1/2", (265 mm), working length: , 5 1/2", (140 mm), blunt, tip length: 1,70 mm, round handle, non-sterile, reusable
Catalog Number
FA039R
Brand Name
TREND
Version/Model Number
FA039R
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)
Yes
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
66d8552e-6aab-4346-9364-98b58d4b7029
Public Version Date
July 20, 2021
Public Version Number
2
DI Record Publish Date
July 06, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |