Duns Number:962874897
Device Description: 12 mm R-Med Plug is used for retention of pneumoperitoneum during 12mm trocar defect closu 12 mm R-Med Plug is used for retention of pneumoperitoneum during 12mm trocar defect closure. To be used with Riza-Ribe or GraNee needle.
Catalog Number
10154
Brand Name
R-Med, Inc.
Version/Model Number
10154
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K942411,K942411
Product Code
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
ea2b5790-7662-4671-8f0a-18d5c23645bf
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
July 24, 2017
Package DI Number
B445101542
Quantity per Package
10
Contains DI Package
B44510154
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box