Duns Number:839138955
Device Description: A device designed to protect and elevate the tips of surgical instruments secured onto a s A device designed to protect and elevate the tips of surgical instruments secured onto a sterilization/instrument stringer placed in a surgical tray.
Catalog Number
IB100M
Brand Name
AED Instrument Bridge - Medium
Version/Model Number
IB100M
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
-
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
e325d5a5-dad1-4b29-80c2-599d9e6e9a6f
Public Version Date
July 20, 2021
Public Version Number
1
DI Record Publish Date
July 12, 2021
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 | 579 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6418 |