Duns Number:792528510
Device Description: Keyhole Bracket, hole opening 15mm (.590"), silicone height 38.1mm (1.5"), OL 39.37mm (1.5 Keyhole Bracket, hole opening 15mm (.590"), silicone height 38.1mm (1.5"), OL 39.37mm (1.55")
Catalog Number
-
Brand Name
IMS
Version/Model Number
95-2000162010
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
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
8b04aa28-65f9-4fcf-99e2-664b0c576c27
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
January 24, 2020
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 | 6832 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9482 |