00711841

GUDID 00816765012062

The Bipolar Hemostatic Probe is passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract.

US Endoscopy

Endoscopic electrosurgical electrode, bipolar, single-use
Primary Device ID00816765012062
NIH Device Record Keyf8c6a987-f4b4-4aa1-a839-c286a6f9d84a
Commercial Distribution Discontinuation2020-03-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number00711841
Catalog Number00711841
Company DUNS627879687
Company NameUS Endoscopy
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 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)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Dimensions

Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100816765012062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNSUnit, electrosurgical, endoscopic (with or without accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2020-03-31
Device Publish Date2016-09-17

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