Duns Number:799751953
Device Description: Brevi-XL™ PRO 19g x 14"
Catalog Number
155-2350
Brand Name
Epimed
Version/Model Number
155-2350
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
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
K954584,K954584
Product Code
BSO
Product Code Name
CATHETER, CONDUCTION, ANESTHETIC
Public Device Record Key
ab47a737-1d2f-439b-90a7-9f14e756c8ba
Public Version Date
February 07, 2019
Public Version Number
5
DI Record Publish Date
October 20, 2017
Package DI Number
10818788022117
Quantity per Package
10
Contains DI Package
00818788022110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 293 |