Duns Number:117630237
Device Description: Disposable sizer set: (1) 9-11mm sizer, (1) 13-15mm sizer, (1) 17-20mm sizer
Catalog Number
-
Brand Name
AlloSource ProChondrix Sizer Set
Version/Model Number
58161-01
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
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
169dd07d-4afa-42c7-ae42-804b52ce7b5f
Public Version Date
May 25, 2021
Public Version Number
1
DI Record Publish Date
May 17, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 162 |