Duns Number:079720472
Device Description: Captura Serrated Forceps W/O Spike
Catalog Number
DBF-2.4SN-160-S
Brand Name
Captura
Version/Model Number
G56122
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
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
PTS
Product Code Name
Endoscopic grasping/cutting instrument, non-powered, exempt
Public Device Record Key
93576b6c-1138-49bc-97aa-358a09cd4014
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 06, 2018
Package DI Number
10827002561226
Quantity per Package
10
Contains DI Package
00827002561229
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |