Duns Number:485098284
Device Description: Acetabular reamer ø49mm for implant cup ø48mm
Catalog Number
3700502206715
Brand Name
Cup reamer size 48
Version/Model Number
3700502206715
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
HTO
Product Code Name
Reamer
Public Device Record Key
a62123bc-8415-4da6-b3c5-2528006bb79f
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 22, 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 | 374 |