Duns Number:832696038
Device Description: Snowden-Pencer MIS SNOWDEN-PENCER FIBEROPTIC LIGHT CABLE ACMI/ACMI, ANGLED 5.0MM X 7.5FT
Catalog Number
88-9728
Brand Name
Snowden-Pencer
Version/Model Number
88-9728
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
K901035
Product Code
FST
Product Code Name
LIGHT, SURGICAL, FIBEROPTIC
Public Device Record Key
571c3fe1-f132-48ce-b7b7-4285f2af0c49
Public Version Date
March 31, 2022
Public Version Number
4
DI Record Publish Date
September 23, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |