Duns Number:315018218
Device Description: CCR Retractor Blade, 5 prongs, blunt, depth: 60 mm, width: 24 mm, stainless steel, side lo CCR Retractor Blade, 5 prongs, blunt, depth: 60 mm, width: 24 mm, stainless steel, side loading mechanism, non-sterile, reusable
Catalog Number
BW357R
Brand Name
CCR
Version/Model Number
BW357R
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
0a53ccf1-8401-4cb8-94ea-05f9e1b500ed
Public Version Date
May 01, 2020
Public Version Number
1
DI Record Publish Date
April 23, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |