GYNECARE VERSAPOINT 00464

GUDID 10705031200500

Hysteroscopic System Footswitch

ETHICON INC.

Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical
Primary Device ID10705031200500
NIH Device Record Key94174cac-f325-4d3c-be7c-ef12e8ef04da
Commercial Distribution Discontinuation2021-12-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGYNECARE VERSAPOINT
Version Model Number00464
Catalog Number00464
Company DUNS002144145
Company NameETHICON 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031200500 [Primary]

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-12-16
Device Publish Date2016-09-16

On-Brand Devices [GYNECARE VERSAPOINT]

10705031000957Hysteroscope 4.0mm 12° - High Magnification
10705031000940Hysteroscope 4.0mm 30° - Wide Angle
10705031200517Electrosurgical Generator
10705031200500Hysteroscopic System Footswitch
10705031200494Hysteroscopic System Connector Cable
20705031000992Resectoscope Electrode
10705031000964Resectoscopic System, Outer Sheath, Rotatable, 27 Fr.
10705031000933Resectoscopic System, Obturator, Standard
10705031000926Resectoscopic System, Working Element, Passive
10705031000919Resectoscopic System, Bridge - Hysteroscopic (Obturator - Visual)
20705031000770Electrode - Ball Tip. 5Fr (1.6mm nom.) x 360mm.
20705031001005Resectoscope Electrode - 2.5mm Angled Loop, Resecting
10705031000810Hysteroscopic System Footswitch
10705031000803Hysteroscopic System Connector Cable
20705031000794Electrode - Spring Tip. 5Fr (1.6mm nom.) x 360mm.
20705031000787Electrode - Twizzle Tip. 5Fr (1.6mm nom.) x 360mm.
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