Duns Number:483016148
Device Description: Plate template 3 level 58mm
Catalog Number
TRY-IN 08 58-N
Brand Name
TRYPTIK 2 C-PLATE INSTRUMENTATION
Version/Model Number
TRY-IN 08 58-N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 03, 2018
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
HWT
Product Code Name
Template
Public Device Record Key
3fed5986-6e8f-4bd5-a951-dbc323f67771
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
August 03, 2018
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 | 974 |
2 | A medical device with a moderate to high risk that requires special controls. | 5209 |