Duns Number:144998551
Device Description: Gastrointestinal Boundary Identification and Sizing Tube 36 French
Catalog Number
B-2036
Brand Name
GIBI HD
Version/Model Number
B-2036
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
K221898
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
44f37904-6791-439a-a6ae-23a86878a0a5
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 07, 2022
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |
3 | A medical device with high risk that requires premarket approval | 20 |