Duns Number:832696038
Device Description: Snowden-Pencer Plastics RETRACTOR CONVERSE, WITH FIBER-OPTICS 5CM (2") TAPERED BLADE
Catalog Number
88-1026
Brand Name
Snowden-Pencer
Version/Model Number
88-1026
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 09, 2021
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
FDG
Product Code Name
RETRACTOR, FIBEROPTIC
Public Device Record Key
3be6c247-905b-4a43-9b3c-43dfb9da27fa
Public Version Date
March 04, 2022
Public Version Number
2
DI Record Publish Date
July 12, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |