Duns Number:058614483
Device Description: Gamma Probe Drape,For Use with Navigator GPS System
Catalog Number
-
Brand Name
Auto Suture
Version/Model Number
098004
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
K961321,K961321
Product Code
IZD
Product Code Name
Probe, uptake, nuclear
Public Device Record Key
a8bc7456-c23c-42ac-9c4a-f7b6e3c34e08
Public Version Date
September 01, 2021
Public Version Number
3
DI Record Publish Date
August 10, 2018
Package DI Number
20884521170282
Quantity per Package
12
Contains DI Package
10884521170285
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |