Duns Number:071595540
Device Description: HALL OSTEON IRRIGATION TUBING SET, QTY 5
Catalog Number
5038-600
Brand Name
HALL OSTEON
Version/Model Number
5038-600
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 08, 2022
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
ff59a1d6-432c-40f5-ad03-f9905df047dd
Public Version Date
June 09, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
20845854018368
Quantity per Package
5
Contains DI Package
10845854018361
Package Discontinue Date
June 08, 2022
Package Status
Not 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 |