Duns Number:015272206
Device Description: Ambler elevator, 15'', angled 90 degrees, reverse curved, 6.0mm x 19.0mm wide blade, round Ambler elevator, 15'', angled 90 degrees, reverse curved, 6.0mm x 19.0mm wide blade, round handle
Catalog Number
20-119
Brand Name
Ambler Surgical
Version/Model Number
Ambler elevator
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
KAD
Product Code Name
ELEVATOR, ENT
Public Device Record Key
ed184c72-3f82-40f8-8b98-a78c5c27b591
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 07, 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 | 14984 |
2 | A medical device with a moderate to high risk that requires special controls. | 3118 |