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 ID: B44510154
• NIH Device Record Key: ea2b5790-7662-4671-8f0a-18d5c23645bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-Med, Inc.
• Version Model Number: 10154
• Catalog Number: 10154
• Company DUNS: 962874897
• Company Name: R-MED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter
• Length: 3 Inch
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B44510154 [Primary]
HIBCC	B445101542 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942411

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-07-24

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

• B44510165: The GraNee Needle is as a Grasper and a Needle used during Laparoscopy, Mini-Laparoscopy and Ope
• B44510154: 12 mm R-Med Plug is used for retention of pneumoperitoneum during 12mm trocar defect closure. To
• B44510152: 10 mm R-Med Plug is used for retention of pneumoperitoneum during 10 mm trocar defect closure. T