R-Med, Inc. 10154

GUDID B44510154

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.

R-MED, INC.

Nonimplantable needle guide, single-use
Primary Device IDB44510154
NIH Device Record Keyea2b5790-7662-4671-8f0a-18d5c23645bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameR-Med, Inc.
Version Model Number10154
Catalog Number10154
Company DUNS962874897
Company NameR-MED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter
Length3 Inch
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB44510154 [Primary]
HIBCCB445101542 [Package]
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HETLaparoscope, Gynecologic (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2017-07-24

On-Brand Devices [R-Med, Inc.]

B44510165The GraNee Needle is as a Grasper and a Needle used during Laparoscopy, Mini-Laparoscopy and Ope
B4451015412 mm R-Med Plug is used for retention of pneumoperitoneum during 12mm trocar defect closure. To
B4451015210 mm R-Med Plug is used for retention of pneumoperitoneum during 10 mm trocar defect closure. T

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