Duns Number:005527098
Device Description: Drain tube attachment device - Accommodates 10Fr to 24Fr tubes
Catalog Number
-
Brand Name
Hollister
Version/Model Number
9780
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K862573,K862573,K862573
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
23c1b631-f36e-4444-9649-a66b506a7c16
Public Version Date
August 08, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
20610075097801
Quantity per Package
24
Contains DI Package
00610075097807
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |