FDA.reportPublic FDA data

R-Med, Inc.

Primary DI
B44510165
Brand
R-Med, Inc.
Company
R-MED, INC.
Model
10165
Catalog number
10165
Device description
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.
Published
2018-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B445101652PackageHIBCC10In Commercial Distribution
B44510165PrimaryHIBCC0

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
Length7Inch
Needle Gauge16Gauge

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
B44510154R-Med, Inc.10154101542017-07-24

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Primary DI, Brand, Company table
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