Duns Number:080819836
Device Description: Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Medium Footprint, 4/5mm Thi Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Medium Footprint, 4/5mm Thickness
Catalog Number
-
Brand Name
restor3d Disposable Instrument, Wedge Trial
Version/Model Number
6100-NSP-B0405
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
36c48444-9872-475a-ab89-315c34439e45
Public Version Date
November 23, 2021
Public Version Number
1
DI Record Publish Date
November 15, 2021
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 | 156 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |