Duns Number:021717889
Device Description: Video Camera Insert - For Rigid Endoscopes
Catalog Number
0010-0728
Brand Name
Video Camera Insert
Version/Model Number
0010-0728
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
-
Product Code
FEM
Product Code Name
ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)
Public Device Record Key
d7b21ad1-9b68-4847-a7be-3e6bea6d6382
Public Version Date
May 22, 2019
Public Version Number
1
DI Record Publish Date
May 14, 2019
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |