FDA.reportPublic FDA data

R-Med, Inc.

Primary DI
B44510154
Brand
R-Med, Inc.
Company
R-MED, INC.
Model
10154
Catalog number
10154
Device description
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.
Published
2017-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942411000R-MED DISPOSABLE PLUGR-Med, Inc.1995-03-31HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B445101542PackageHIBCC10In Commercial Distribution
B44510154PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Inch
Outer Diameter12Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962874897
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B44510152R-Med, Inc.10152101522017-08-14
B44510165R-Med, Inc.10165101652018-10-23

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