Duns Number:327681359
Device Description: YASARGIL HOLDER FOR FLAT BRAIN SPATULA, COMPLETE, WITH 2 FLEXIBLE ARMS CONSISTING OF 70.26 YASARGIL HOLDER FOR FLAT BRAIN SPATULA, COMPLETE, WITH 2 FLEXIBLE ARMS CONSISTING OF 70.268.02 / 2x 70.270.02 / 2x 70.273.02
Catalog Number
70.262.02
Brand Name
LAZIC
Version/Model Number
70.262.02
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
-
Product Code
GAD
Product Code Name
Retractor
Public Device Record Key
d955a8d4-9587-4176-b6ca-63bc06ce8fb6
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 2021
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 | 1084 |
2 | A medical device with a moderate to high risk that requires special controls. | 1125 |