Duns Number:007883297
Device Description: Spetzler Lighted Suction Tube, 5 French, 140mm, Storz Conenctor
Catalog Number
-
Brand Name
Spetzler Lighted Suction Tube, 5 French, 140mm, Storz Conenctor
Version/Model Number
DN1405-140
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141781,K141781
Product Code
FST
Product Code Name
Light, Surgical, Fiberoptic
Public Device Record Key
9551fa1e-8dec-4cc3-86c3-856234edddf9
Public Version Date
April 20, 2020
Public Version Number
5
DI Record Publish Date
July 18, 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 | 1640 |
2 | A medical device with a moderate to high risk that requires special controls. | 288 |