Duns Number:315304071
Device Description: 3D-ENDOSCOPE 30° Ø 10MM WL 435MM rigid, TL 501mm, rod lens system
Catalog Number
89344632
Brand Name
NA
Version/Model Number
89344632
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FWG
Product Code Name
CAMERA, TELEVISION, ENDOSCOPIC, WITH AUDIO
Public Device Record Key
153d3ff3-53e6-4124-b775-48fc707c3579
Public Version Date
April 30, 2021
Public Version Number
3
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 | 587 |
2 | A medical device with a moderate to high risk that requires special controls. | 1835 |