Duns Number:065016344
Device Description: 4.2MM BLUNT OBTURATOR
Catalog Number
84-24-4032
Brand Name
ZEOS
Version/Model Number
84-24-4032
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
NBH
Product Code Name
Accessories, Arthroscopic
Public Device Record Key
704c8637-4079-4b3c-9433-c3b024871d6e
Public Version Date
September 24, 2018
Public Version Number
1
DI Record Publish Date
August 24, 2018
Package DI Number
00812231030820
Quantity per Package
1
Contains DI Package
00812231030110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Loaner
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |