Duns Number:276593071
Device Description: Tiger insert for tube 5mm diam., 210mm length
Catalog Number
CEV8613T1U
Brand Name
Integra®
Version/Model Number
CEV8613T1U
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
K080257
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
82820db4-d54c-4c62-8e43-36c1355f8d02
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
April 04, 2019
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 | 1433 |
2 | A medical device with a moderate to high risk that requires special controls. | 879 |