Duns Number:832637081
Device Description: UNIVERSAL GRAPHIC CASE BOTTOM
Catalog Number
30601
Brand Name
NA
Version/Model Number
306.01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2019
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
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
998ad010-0691-453b-ad6b-f8cb1601152a
Public Version Date
March 01, 2019
Public Version Number
4
DI Record Publish Date
December 31, 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 | 1194 |
2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
3 | A medical device with high risk that requires premarket approval | 30 |
U | Unclassified | 1 |