Duns Number:314482980
Catalog Number
52555
Brand Name
4 In1 Cut Block Temp Zimmer Nk Ii
Version/Model Number
52555
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
K102990
Product Code
OLO
Product Code Name
Orthopedic Stereotaxic Instrument
Public Device Record Key
dcfc5cc4-f2df-4d11-b0bb-f92437d29226
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
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 | 48 |
2 | A medical device with a moderate to high risk that requires special controls. | 685 |