Histolock 00711117

GUDID 10724995182622

The Histolock resection device is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

STERIS CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID10724995182622
NIH Device Record Key0c5d80fd-5b51-4a79-887b-c2bf0d7e673c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHistolock
Version Model Number00711117
Catalog Number00711117
Company DUNS139424188
Company NameSTERIS CORPORATION
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Dimensions

Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter
Width14 Millimeter
Length230 Centimeter
Outer Diameter2.4 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995182625 [Primary]
GS100816765012727 [Previous]
GS110724995182622 [Package]
Contains: 00724995182625
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDISNARE, FLEXIBLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-27
Device Publish Date2020-03-19

Devices Manufactured by STERIS CORPORATION

00724995225087 - NA2024-11-15 LED202 IN CEILING SINGLE LIGHTING SYSTEM
00724995225094 - NA2024-11-15 LED202 IN CEILING DUAL LIGHTING SYSTEM
00724995201876 - STERIS2024-10-28 STERIS 4095 SP TABLE 120V SS with Velcro attachment and 2-inch TLT Pads
00724995228156 - NA2024-10-28 2 inch TLT Pads for 7000 series Split Legs Velcro concave
00724995228170 - NA2024-10-28 3 inch TLT Pads for 7000 series Split Legs Velcro concave
00724995228187 - NA2024-10-28 3 inch TLT Pads for 7000 series Split Legs Velcro flat
00724995228194 - NA2024-10-28 4 inch TLT Pads for 7000 series Split Legs Velcro concave
00724995228200 - NA2024-10-28 4 inch TLT Pads for 7000 series Split Legs Velcro flat

Trademark Results [Histolock]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HISTOLOCK
HISTOLOCK
86309459 4796501 Live/Registered
UNITED STATES ENDOSCOPY GROUP, INC.
2014-06-13

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