Duns Number:320249162
Device Description: DELTA XS Retractor Blade 65mm, curved, medial / lateral
Catalog Number
207-060-0116
Brand Name
NA
Version/Model Number
207-060-0116
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
GAD
Product Code Name
RETRACTOR
Public Device Record Key
9c554beb-1b14-418a-9b59-2cd8af964373
Public Version Date
July 08, 2019
Public Version Number
2
DI Record Publish Date
November 20, 2018
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 | 359 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |