Duns Number:002348191
Device Description: AUTOMATIC ENDOSCOPIC 10 LARGE
Catalog Number
AE10LG
Brand Name
WECK
Version/Model Number
IPN039776
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161758,K161758,K161758,K161758,K161758
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
399a0c7f-4e9b-46ad-98be-f033bdd99bcd
Public Version Date
July 09, 2019
Public Version Number
1
DI Record Publish Date
July 01, 2019
Package DI Number
44026704667473
Quantity per Package
6
Contains DI Package
34026704667476
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |