Duns Number:486711679
Device Description: RETRACTOR BLADE 35MM X 24MM NOTCHED
Catalog Number
SD03615935
Brand Name
NA
Version/Model Number
SD03.615.935
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)
Yes
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
0c17e4c7-392d-47b4-98d6-649d06dd9653
Public Version Date
April 27, 2022
Public Version Number
5
DI Record Publish Date
December 31, 2016
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 | 8630 |
2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
U | Unclassified | 2 |