Duns Number:149818952
Device Description: Tunneling Tool, 0.156"¿ Diameter
Catalog Number
1191
Brand Name
NA
Version/Model Number
1191
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
HAO
Product Code Name
INSTRUMENT, SURGICAL, NON-POWERED
Public Device Record Key
f6bd1738-59a7-476a-bd70-0d767eae2082
Public Version Date
April 02, 2018
Public Version Number
1
DI Record Publish Date
February 28, 2018
Package DI Number
15414734400661
Quantity per Package
3
Contains DI Package
05414734400664
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |