Duns Number:109903521
Device Description: DIRECT-VIEW AUTOCLAVABLE BARIATRIC LAPAROSCOPES 10 MM O DIRECT-VIEW AUTOCLAVABLE BARIATRIC LAPAROSCOPES 10 MM OUTER DIAMETER, 30 DEGREE DIRECTION OF VIEW, 81 DEGREE FIELD OF VIEW, 330 MM WORKING LENGTH, SERVICE REPLACEMENT
Catalog Number
72202464S
Brand Name
NA
Version/Model Number
72202464S
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
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
86be5910-ce3d-4563-9e7d-9acc1b07c495
Public Version Date
October 09, 2020
Public Version Number
3
DI Record Publish Date
June 15, 2017
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |