Duns Number:313088331
Device Description: Collapsed Disc Space Opener
Catalog Number
-
Brand Name
EIT PLIF Disc space opener
Version/Model Number
PET10051
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
K170503
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
e620d0af-14ac-4181-a919-749081c61f80
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 13, 2019
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 | 234 |
2 | A medical device with a moderate to high risk that requires special controls. | 1726 |