Duns Number:004382282
Device Description: RICHARDSON RETRACTOR; 9-1/2''(24CM), (1 1/2'' WIDE X 1-1/2'' DEEP) BLADE, HOLLOW GRIP HAND RICHARDSON RETRACTOR; 9-1/2''(24CM), (1 1/2'' WIDE X 1-1/2'' DEEP) BLADE, HOLLOW GRIP HANDLE,
Catalog Number
B61233
Brand Name
N/A
Version/Model Number
B61233
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
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
17a40d4f-ac65-4fc9-b5ae-c3a206d89ffa
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 | 5533 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 240 |