Duns Number:784259751
Device Description: GUIDEWIRE, 018 X 300CM NIT/GOLD STRAIGHT
Catalog Number
612153
Brand Name
B.BRAUN
Version/Model Number
612153
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
Yes
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
K021990,K021990
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
12c875d0-fbcf-476a-a03d-4eccb0c95efd
Public Version Date
May 06, 2019
Public Version Number
1
DI Record Publish Date
April 26, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1226 |
3 | A medical device with high risk that requires premarket approval | 361 |