Duns Number:079344210
Catalog Number
e2504-01
Brand Name
Symmetry Surgical
Version/Model Number
e2504-01
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
Yes
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
GAD
Product Code Name
Retractor
Public Device Record Key
e4680693-afcd-4ecc-b237-4408cdbf5f8e
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
July 02, 2019
Package DI Number
30841785113384
Quantity per Package
4
Contains DI Package
00841785113383
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10 |
2 | A medical device with a moderate to high risk that requires special controls. | 1233 |