Epimed 231-1610

GUDID 10818788023152

R-F™ B Bevel 16g RW 10cm w/ 10mm Straight Active Tip

EPIMED INTERNATIONAL, INC

Radio-frequency ablation system probe cannula, single-use
Primary Device ID10818788023152
NIH Device Record Keyb9b43723-85aa-490b-96dc-eb116694c15a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpimed
Version Model Number231-1610
Catalog Number231-1610
Company DUNS799751953
Company NameEPIMED INTERNATIONAL, INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com
Phone+1(800)866-3342
Emailcustomerservice@epimed.com

Device Dimensions

Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge16 Gauge
Length10 Millimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100818788023155 [Primary]
GS110818788023152 [Package]
Contains: 00818788023155
Package: Case [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXIProbe, radiofrequency lesion

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


[10818788023152]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-12
Device Publish Date2020-06-04

On-Brand Devices [Epimed]

00818788023193PainBlocker™ 16g x 3" Hemi Cryoneuroablation Probe
10818788023022Grounding Pad, 4" x 8" w/ Attached Cable
10818788022988Grounding Pad Cable, 10"
10818788022971Grounding Pad, 4" x 8"
00818788022820PainBlocker™ Cryoneuroablation Probe Sterilization Tray
00818788022806PainBlocker™ 18g x 6" Trocar Cryoneuroablation Probe
00818788022790PainBlocker™ 18g x 6" Hemi Cryoneuroablation Probe
00818788022783PainBlocker™ 16g x 6" Trocar Cryoneuroablation Probe
00818788022776PainBlocker™ 16g x 3" Trocar Cryoneuroablation Probe
00818788022769PainBlocker™ 16g x 6" Hemi Cryoneuroablation Probe
00818788022752PainBlocker™ 15g x 6" Bevel Point Cryoneuroablation Probe
00818788022745PainBlocker™ 14g x 6" Trocar Cryoneuroablation Probe
00818788022738PainBlocker™ 14g x 6" Hemi Cryoneuroablation Probe
00818788022721PainBlocker™ System
00818788022714PainBlocker™ Cart
10818788022667R-F™ Cannula Coudé® B Bevel 22g TW x 15cm w/ 10mm Active Tip
10818788022650R-F™ Cannula Coudé® B-Bevel 22g x 10cm w/ 10mm Active Tip
10818788022643R-F™ Cannula Coudé® B-Bevel 20g x 15cm w/ 10mm Active Tip
10818788022636R-F™ Cannula Coudé® B-Bevel 20g x 10cm w/ 10mm Active Tip
10818788022629R-F™ Cannula Coudé® B-Bevel 18g x 15cm w/ 10mm Active Tip
10818788022612R-F™ Cannula Coudé® B-Bevel 18g x 10cm w/ 10mm Active Tip
10818788022605R-F™ Cannula Coudé® B-Bevel 16g x 15cm w/ 10mm Active Tip
10818788022599R-F™ Cannula Coudé® B-Bevel 16g x 10cm w/ 10mm Active Tip
10818788022582R-F™ Cannula Coudé® B Bevel 22g TW x 15cm w/ 5mm Active Tip
10818788022575R-F™ Cannula Coudé® B-Bevel 22g x 10cm w/ 5mm Active Tip
10818788022568R-F™ Cannula Coudé® B-Bevel 22g x 5cm w/ 5mm Active Tip
10818788022551R-F™ Cannula Coudé® B Bevel 20g TW x 15cm w/ 5mm Active Tip
10818788022544R-F™ Cannula Coudé® B-Bevel 20g x 10cm w/ 5mm Active Tip
10818788022537R-F™ Cannula Coudé® B Bevel 20g RW x 5cm w/ 5mm Active Tip
10818788022520R-F™ Cannula B Bevel 22g TW x 15cm w/ 10mm Active Tip
10818788022513R-F™ Cannula B-Bevel 22g x 10cm w/ 10mm Active Tip
10818788022506R-F™ Cannula B-Bevel 20g x 15cm w/ 10mm Active Tip
10818788022490R-F™ Cannula B-Bevel 20g x 10cm w/ 10mm Active Tip
10818788022483R-F™ Cannula B-Bevel 18g x 15cm w/ 10mm Active Tip
10818788022476R-F™ Cannula B-Bevel 18g x 10cm w/ 10mm Active Tip
10818788022469R-F™ Cannula B Bevel 22g TW x 15cm w/ 5mm Active Tip
10818788022452R-F™ Cannula B-Bevel 22g x 10cm w/ 5mm Active Tip
10818788022445R-F™ Cannula B-Bevel 22g x 5cm w/ 5mm Active Tip
10818788022438R-F™ Cannula B-Bevel 20g x 15cm w/ 5mm Active Tip
10818788022421R-F™ Cannula B-Bevel 20g x 10cm w/ 5mm Active Tip
10818788022414R-F™ Cannula B Bevel 20g TW x 5cm w/ 5mm Active Tip
10818788022377R-F Cannula Coudé Blunt 22g TW x 10cm with 15mm Active Tip
10818788022360R-F Cannula Coudé Blunt 22g TW x 10cm with 3mm Active Tip
10818788022353R-F Cannula Blunt 22g TW x 15cm with 15mm Active Tip
10818788022346R-F Cannula Blunt 22g TW x 10cm with 15mm Active Tip
10818788022339R-F Cannula Blunt 20g TW x 10cm with 15mm Active Tip
10818788022322R-F Cannula Blunt 22g TW x 15cm with 3mm Active Tip
10818788022315R-F Cannula Blunt 22g TW x 10cm with 3mm Active Tip
10818788022285RX-2 Coudé Epidural Needle 13g TW x 6.0"
10818788022278RX-2 Coudé Coude Epidural Needle 13g TW x 4.0"

Trademark Results [Epimed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPIMED
EPIMED
85328075 4192855 Live/Registered
EPIMED INTERNATIONAL, INC.
2011-05-23
EPIMED
EPIMED
85328059 4192854 Live/Registered
EPIMED INTERNATIONAL, INC.
2011-05-23
EPIMED
EPIMED
75338282 2312847 Dead/Cancelled
PROVANTAGE HEALTH SERVICES, INC.
1997-08-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.