Duns Number:343548848
Device Description: Circular frame Ø290 with serrated washerfor BluCLAS G BLUE LAB Circular frame Ø290 with serrated washerfor BluCLAS G BLUE LABEL™
Catalog Number
UL7084-29
Brand Name
Circular frame Ø290 with serrated washer for BluCLAS
Version/Model Number
UL7084-29
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"
Yes
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
GZT
Product Code Name
RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
Public Device Record Key
7703f4d7-44ce-4d47-b8e2-566cce9164ed
Public Version Date
November 19, 2018
Public Version Number
1
DI Record Publish Date
October 18, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 792 |