Duns Number:315018218
Device Description: COOLEY Atrium Retractor, 9 1/4", (235 mm), depth: 50 mm, width: 35 mm, non-sterile, reusab COOLEY Atrium Retractor, 9 1/4", (235 mm), depth: 50 mm, width: 35 mm, non-sterile, reusable
Catalog Number
FB968R
Brand Name
AESCULAP
Version/Model Number
FB968R
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
GDG
Product Code Name
HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
3f5e608f-ce2f-48f1-9f07-a740528b2f39
Public Version Date
August 26, 2020
Public Version Number
2
DI Record Publish Date
April 24, 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 |