Duns Number:481999654
Device Description: Screw Marker 21,9
Catalog Number
52-02109
Brand Name
NA
Version/Model Number
52-02109
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
5aed7738-928b-4da3-8b7c-921c18d53120
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2018
Package DI Number
37613154639749
Quantity per Package
2
Contains DI Package
07613154639748
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2606 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9953 |
| 3 | A medical device with high risk that requires premarket approval | 186 |