Duns Number:962874897
Device Description: The GraNee Needle is as a Grasper and a Needle used during Laparoscopy, Mini-Laparoscopy a The GraNee Needle is as a Grasper and a Needle used during Laparoscopy, Mini-Laparoscopy and Operative Laparoscopy for suture passing and retrieval, trocar port closure and hernia repair.
Catalog Number
10165
Brand Name
R-Med, Inc.
Version/Model Number
10165
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
bea112bb-92ae-412c-ad1f-15249ae79881
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
October 23, 2018
Package DI Number
B445101652
Quantity per Package
10
Contains DI Package
B44510165
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box