Duns Number:832696038
Device Description: Snowden-Pencer MIS SNOWDEN PENCER RETRACTOR PITIE-SALPETRIERE "C" 20CM (8"), ANGLED BLADES Snowden-Pencer MIS SNOWDEN PENCER RETRACTOR PITIE-SALPETRIERE "C" 20CM (8"), ANGLED BLADES DEBAKEY TEETH
Catalog Number
89-2407
Brand Name
Snowden-Pencer
Version/Model Number
89-2407
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 15, 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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
95283e4a-4981-4dfe-879f-e20a2fcb8ad9
Public Version Date
March 04, 2022
Public Version Number
2
DI Record Publish Date
July 13, 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 |