Duns Number:011560431
Device Description: Retractor 90x60mm with Built-In Single-Use Multi-LED Light Source - STERILE
Catalog Number
-
Brand Name
ONETRAC LX
Version/Model Number
C100230
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAD
Product Code Name
Retractor
Public Device Record Key
0605cfc2-01b6-4b47-98e7-b3714979cd7b
Public Version Date
October 31, 2019
Public Version Number
1
DI Record Publish Date
October 23, 2019
Package DI Number
M648C1002302
Quantity per Package
10
Contains DI Package
M648C1002301
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |