Duns Number:040729840
Device Description: WALTER AUFRICHT NASAL RETRACTOR DOUBLE ENDED
Catalog Number
207-2928
Brand Name
WALTER AUFRICHT NASAL RETRACTOR
Version/Model Number
207-2928
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
KAL
Product Code Name
RETRACTOR, ENT
Public Device Record Key
50915681-7ee8-4864-9bd1-6f51f9ca96d1
Public Version Date
October 12, 2018
Public Version Number
1
DI Record Publish Date
September 11, 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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |