Duns Number:559966539
Catalog Number
-
Brand Name
Reloading Unit for Endo Linear Cutter Stapler
Version/Model Number
CADB-30T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142577
Product Code
GDW
Product Code Name
Staple, Implantable
Public Device Record Key
62d60365-446e-497c-8b50-894e7e26b5a5
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 04, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 96 |