Duns Number:592616445
Device Description: A surgical instrument connected to an active device intended to be used during an orthopae A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
Catalog Number
4250-7050
Brand Name
Enztec ORD – Locking – Crossbar - Zimmer
Version/Model Number
4250-7050
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWE
Product Code Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Public Device Record Key
4610b4a0-732c-47da-b34f-049d150a1527
Public Version Date
March 14, 2022
Public Version Number
1
DI Record Publish Date
March 04, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 107 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |