Duns Number:618214410
Device Description: Carroll Prostatic Malleable Retractor Blade 1-1/2" spreads to 3-1/2" x 7", with ratchet ha Carroll Prostatic Malleable Retractor Blade 1-1/2" spreads to 3-1/2" x 7", with ratchet handle
Catalog Number
108-842
Brand Name
Hayden Medical
Version/Model Number
108-842
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
FFO
Product Code Name
RETRACTOR, SELF-RETAINING
Public Device Record Key
3059bfd2-4e1f-4966-9e00-56b3ab41a6f6
Public Version Date
September 20, 2022
Public Version Number
1
DI Record Publish Date
September 12, 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 |