Duns Number:315304071
Device Description: RECTOSCOPE TUBE Ø 22MM WL 260MM WL 260mm, TL 307mm, insulated distal end, reusable
Catalog Number
8834.025
Brand Name
NA
Version/Model Number
8834025
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 26, 2016
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
GCM
Product Code Name
ENDOSCOPE, RIGID
Public Device Record Key
362371ab-f472-4935-842c-fec7d96752d4
Public Version Date
June 16, 2022
Public Version Number
4
DI Record Publish Date
September 26, 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 |