Duns Number:830350380
Device Description: CDHL 5.5 ROD ADD-ON LID, TI
Catalog Number
-
Brand Name
N/A
Version/Model Number
7059420L
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
99a09c76-7684-44dd-a926-74bdc7447854
Public Version Date
September 16, 2022
Public Version Number
8
DI Record Publish Date
September 24, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 13352 |
2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
3 | A medical device with high risk that requires premarket approval | 190 |
U | Unclassified | 75 |