Duns Number:799751953
Device Description: Percutaneous Introducer w/ 14g RW x 2.75" B Bevel needle with sidearm injection port and h Percutaneous Introducer w/ 14g RW x 2.75" B Bevel needle with sidearm injection port and hemostasis valve
Catalog Number
138-1427
Brand Name
Epimed International, Inc.
Version/Model Number
138-1427
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
K051860,K051860
Product Code
MIA
Product Code Name
NEEDLE, SPINAL, SHORT TERM
Public Device Record Key
29852c02-83f6-41be-8c4d-ad92d57526de
Public Version Date
May 13, 2022
Public Version Number
1
DI Record Publish Date
May 05, 2022
Package DI Number
10818788023695
Quantity per Package
10
Contains DI Package
00818788023698
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 |