Duns Number:047644935
Device Description: Suture Grasper Closure Device
Catalog Number
76021-01M
Brand Name
RSG-14F-4
Version/Model Number
D1001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCF
Product Code Name
Instrument, Ligature Passing And Knot Tying
Public Device Record Key
31adbe7a-5598-4cfe-acdc-a0d7fd4775c6
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
November 11, 2016
Package DI Number
10842102105040
Quantity per Package
10
Contains DI Package
00842102105043
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 | 882 |
2 | A medical device with a moderate to high risk that requires special controls. | 595 |