Duns Number:315018218
Device Description: YASARGIL XS Clip Applier Forceps, 9 1/2", (240 mm), working length: 4 3/8", (110 mm), bayo YASARGIL XS Clip Applier Forceps, 9 1/2", (240 mm), working length: 4 3/8", (110 mm), bayonet-shaped, with ratchet, mini, phynox
Catalog Number
FE491K
Brand Name
AESCULAP
Version/Model Number
FE491K
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
HCI
Product Code Name
APPLIER, ANEURYSM CLIP
Public Device Record Key
f866855c-e051-4102-8e9b-181de4d56a6a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 19, 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 | 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 |