Duns Number:832696038
Device Description: COTTLE SEPTUM ELEVATOR DOUBLE-ENDED, 3MM SPATULA & 4X4 SHARP ROUND END OVERALL LENGTH 9" ( COTTLE SEPTUM ELEVATOR DOUBLE-ENDED, 3MM SPATULA & 4X4 SHARP ROUND END OVERALL LENGTH 9" (23CM)
Catalog Number
88-3873
Brand Name
Snowden-Pencer
Version/Model Number
88-3873
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
GEG
Product Code Name
ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
ad1077d9-f006-47ae-9c0a-45b8eac5b6cc
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
July 13, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |