Duns Number:071595540
Device Description: SIGMOIDOSCOPIC Suction Instrument 18 Fr W/Winged Cap Control & 6' (1.8m) Tubing
Catalog Number
0033050
Brand Name
SIGMOIDOSCOPIC
Version/Model Number
0033050
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Public Device Record Key
5641fb43-76f5-4cf6-aa17-337a07e4568c
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
July 02, 2018
Package DI Number
20653405001949
Quantity per Package
20
Contains DI Package
10653405001942
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |