Duns Number:002348191
Device Description: Extraction bag, for 10 mm trocars
Catalog Number
332802-000010
Brand Name
WECK
Version/Model Number
IPN027866
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"
Yes
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
KGY
Product Code Name
BAG, INTESTINE
Public Device Record Key
c26ace05-763a-4c16-ab1f-9753914b2ebd
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 21, 2018
Package DI Number
24026704112511
Quantity per Package
5
Contains DI Package
14026704112514
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |