Duns Number:485098284
Device Description: Offset Acetabular Reamer Driver - drive chain accessory for 55° angled reamer handle - non Offset Acetabular Reamer Driver - drive chain accessory for 55° angled reamer handle - non-captive
Catalog Number
481100595
Brand Name
55 DEGREE CONSTRAINED U JOINT DRIVE CHAIN
Version/Model Number
481100595
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
a6ee63c5-38a8-4283-bc89-a2d0096d5393
Public Version Date
July 27, 2020
Public Version Number
1
DI Record Publish Date
July 17, 2020
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 | 374 |