Duns Number:607846297
Device Description: CODMAN LEROY Scalp Clip Applier Forceps Adult Size 185mm Long
Catalog Number
205117
Brand Name
CODMAN
Version/Model Number
20-5117
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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
GDO
Product Code Name
APPLIER, SURGICAL, CLIP
Public Device Record Key
0be71e6a-1b2e-4e36-9c2d-7b5cd56c1311
Public Version Date
September 01, 2022
Public Version Number
4
DI Record Publish Date
June 30, 2016
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1054 |
| 3 | A medical device with high risk that requires premarket approval | 11 |