Duns Number:010712461
Device Description: Curaplex 8in Exten Set Rmvble Sure Lok NeedleFree Connect Pnch Clmp Rotating Male LL 1 EA Curaplex 8in Exten Set Rmvble Sure Lok NeedleFree Connect Pnch Clmp Rotating Male LL 1 EA 50EA per CS
Catalog Number
1714-31081
Brand Name
Curaplex
Version/Model Number
1714-31081
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
42903e5e-cadb-4b90-9e87-af99b51ad540
Public Version Date
July 09, 2019
Public Version Number
1
DI Record Publish Date
July 01, 2019
Package DI Number
00812277034516
Quantity per Package
50
Contains DI Package
00812277034455
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 92 |
2 | A medical device with a moderate to high risk that requires special controls. | 92 |