Duns Number:058311945
Device Description: Exeter V40 Broach
Catalog Number
0585-3-441
Brand Name
INSTRUMENT
Version/Model Number
0585-3-441
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
JDG
Product Code Name
Prosthesis, hip, femoral component, cemented, metal
Public Device Record Key
f538a59b-bbff-470c-9733-0f8fff6aecb0
Public Version Date
February 22, 2022
Public Version Number
3
DI Record Publish Date
May 03, 2018
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 | 5091 |
2 | A medical device with a moderate to high risk that requires special controls. | 10216 |
3 | A medical device with high risk that requires premarket approval | 32 |