R-Med, Inc. 10165

GUDID B44510165

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.

R-MED, INC.

Nonimplantable needle guide, single-use
Primary Device IDB44510165
NIH Device Record Keybea112bb-92ae-412c-ad1f-15249ae79881
Commercial Distribution StatusIn Commercial Distribution
Brand NameR-Med, Inc.
Version Model Number10165
Catalog Number10165
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length7 Inch
Length7 Inch
Length7 Inch
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch
Needle Gauge16 Gauge
Length7 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB44510165 [Primary]
HIBCCB445101652 [Package]
Package: Box [10 Units]
In Commercial Distribution

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 Number3
Public Version Date2019-10-07
Device Publish Date2018-10-23

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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