Duns Number:316152610
Device Description: WEIL-BLAKESLEY SEPTUM FORCEPS 90° CURVED UP 3.6 MM WORKING LENGTH 12 WEIL-BLAKESLEY SEPTUM FORCEPS 90° CURVED UP 3.6 MM WORKING LENGTH 12 CM
Catalog Number
-
Brand Name
Gimmi
Version/Model Number
QS.1306.01
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"
Yes
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
KAE
Product Code Name
Forceps, Ent
Public Device Record Key
1875bc5d-3760-432d-a38e-d68b02fca812
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 18, 2017
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 925 |