Duns Number:488293218
Device Description: Convenience kit containing:1 x Dominant Flex Rack (item # 071.0003 ) with U.S. power cord Convenience kit containing:1 x Dominant Flex Rack (item # 071.0003 ) with U.S. power cord1 pack of Coupling Piece 90° (item # 077.1019, 10 pieces)1 x IFU of each language region (EU 1, EU 2, Japan, Korea, China)
Catalog Number
101043438
Brand Name
J&J DePuy Synthes convenience kit
Version/Model Number
101043438
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
-
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
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
ffaee3b1-037e-45c4-8d64-6d0d40e280e2
Public Version Date
December 09, 2021
Public Version Number
1
DI Record Publish Date
December 01, 2021
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. | 93 |