Duns Number:618214410
Device Description: Tebbetts Style Endo Breast Retractor 200mm x 25mm w/ Fiberoptic Light & Suction Tube (Toot Tebbetts Style Endo Breast Retractor 200mm x 25mm w/ Fiberoptic Light & Suction Tube (Tooth Serrated End)
Catalog Number
405-293LS
Brand Name
Hayden Medical
Version/Model Number
405-293LS
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
GAD
Product Code Name
RETRACTOR
Public Device Record Key
f2bf56cd-40d3-4f23-87c2-0d99afb63545
Public Version Date
August 24, 2022
Public Version Number
1
DI Record Publish Date
August 16, 2022
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 | 2893 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |