Duns Number:055870299
Device Description: Scalp Elevator Insl., 43cm; Ergo Hdl, 32cm insulated shaft, strong half curve, 15mm BL w/b Scalp Elevator Insl., 43cm; Ergo Hdl, 32cm insulated shaft, strong half curve, 15mm BL w/beveled edges
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.AEP723926E
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEG
Product Code Name
Elevator, Surgical, General & Plastic Surgery
Public Device Record Key
e0e8293e-14c6-4dda-9e94-979c28eeb724
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 08, 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 | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |