Duns Number:058311945
Device Description: EXETER ACETABULAR CEMENT SEAL
Catalog Number
0935-0-066
Brand Name
INSTRUMENT
Version/Model Number
0935-0-066
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
7bd78213-fabd-4774-9949-629c218877ce
Public Version Date
July 10, 2018
Public Version Number
3
DI Record Publish Date
December 01, 2016
Package DI Number
07613327261066
Quantity per Package
5
Contains DI Package
17613327261063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| 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 |