Duns Number:002348191
Device Description: Alligator Grasper
Catalog Number
GBC200
Brand Name
MINILAP
Version/Model Number
IPN914234
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
K070686,K070686,K070686
Product Code
OCW
Product Code Name
Endoscopic tissue approximation device
Public Device Record Key
c2ba7608-7103-4396-9bdb-c551a2c48dc2
Public Version Date
October 01, 2020
Public Version Number
2
DI Record Publish Date
August 26, 2019
Package DI Number
24026704645316
Quantity per Package
6
Contains DI Package
14026704645319
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 |