Duns Number:079641356
Device Description: Tyler Gigli Saw 12
Catalog Number
75-1013
Brand Name
Symmetry GIGLI
Version/Model Number
75-1013
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
GFA
Product Code Name
Blade, Saw, General & Plastic Surgery, Surgical
Public Device Record Key
17eab64a-bee4-4dfe-84d4-3015c5048503
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
December 12, 2017
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 | 7981 |
2 | A medical device with a moderate to high risk that requires special controls. | 3309 |