Duns Number:320249162
Device Description: DELTA XS Retractor Blade 85mm, curved, medial / lateral
Catalog Number
207-060-0118
Brand Name
NA
Version/Model Number
207-060-0118
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
024422c3-5ba6-4e53-8226-37524b3535f2
Public Version Date
July 15, 2019
Public Version Number
1
DI Record Publish Date
July 05, 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 | 359 |
2 | A medical device with a moderate to high risk that requires special controls. | 876 |