Duns Number:327681359
Device Description: D-LINE MICRO PITUITARY CUP BLUNT, MEMORY-SHAFT; NON-ROTATABLE, WORKING LENGHT 110MM, GOLDE D-LINE MICRO PITUITARY CUP BLUNT, MEMORY-SHAFT; NON-ROTATABLE, WORKING LENGHT 110MM, GOLDEN
Catalog Number
46.856.03
Brand Name
LAZIC
Version/Model Number
46.856.03
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
GEN
Product Code Name
Forceps, General & Plastic Surgery
Public Device Record Key
10c5a327-b840-4222-b276-8c83aa5d13f8
Public Version Date
July 06, 2020
Public Version Number
1
DI Record Publish Date
June 26, 2020
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 |