Duns Number:040729840
Device Description: TEBBETTS SUCTION WOUND RETRACTOR ILLUMINATED TOOTHED STRAIGHT EDGE
Catalog Number
-
Brand Name
TEBBETTS SUCTION WOUND RETRACTOR
Version/Model Number
46933-04
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2018
Issuing Agency
In HIBCC
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
FGN
Product Code Name
Retractor, Non-Self-Retaining
Public Device Record Key
b66cdd89-e357-4f5e-9985-2b624a499725
Public Version Date
September 24, 2018
Public Version Number
6
DI Record Publish Date
August 19, 2016
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 |