Duns Number:948025002
Device Description: Ribbon Retractor 13" x 1 1/4"
Catalog Number
-
Brand Name
Life Instruments
Version/Model Number
845-1314-0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
9c0f9362-85e9-4734-81a8-a9d1c876c4ac
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 14, 2021
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 | 5454 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |