Duns Number:832696038
Device Description: Snowden-Pencer MIS SNOWDEN-PENCER HEADLIGHT SYSTEM, ADJUSTABLE SWEATBAND WITH 3.5MM X 9FT Snowden-Pencer MIS SNOWDEN-PENCER HEADLIGHT SYSTEM, ADJUSTABLE SWEATBAND WITH 3.5MM X 9FT BIFURCATED FIBER OPTIC CABLE
Catalog Number
89-8462
Brand Name
Snowden-Pencer
Version/Model Number
89-8462
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 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
K893458
Product Code
EBA
Product Code Name
LIGHT, SURGICAL HEADLIGHT
Public Device Record Key
4e66f04e-86eb-4f48-80bf-2e6ba86ee3b3
Public Version Date
March 04, 2022
Public Version Number
4
DI Record Publish Date
June 06, 2017
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 |