Duns Number:257382580
Device Description: Enucleation/Evisceration Sizers (set: 14, 16, 18, 20 & 22 mm)
Catalog Number
-
Brand Name
Enucleation/Evisceration Sizers (set)
Version/Model Number
A1-SET
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
74f8fc9a-0405-4828-aea3-c265f905ccea
Public Version Date
December 03, 2019
Public Version Number
1
DI Record Publish Date
November 25, 2019
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 | 192 |
2 | A medical device with a moderate to high risk that requires special controls. | 88 |