Batrik H/S Catheter TM 5F 51-5005

GUDID 00690521009318

H/S Catheters are latex free medical devices used to inject contrast media or saline into the uterus through the fluid lumen of the tube. This devices consist of a flexible (size 5FR) tube with a balloon at the distal end. Intended to be used during sonohysterography and Hysterosalpingography procedures.

Batrik Medical Manufacturing Inc

Intrauterine imaging medium catheter
Primary Device ID00690521009318
NIH Device Record Key60ba6aa4-d6c0-406e-8756-c9d061c7b584
Commercial Distribution StatusIn Commercial Distribution
Brand NameBatrik H/S Catheter TM 5F
Version Model Number51-5005
Catalog Number51-5005
Company DUNS243880700
Company NameBatrik Medical Manufacturing 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-631-7988
Emailinfo@surgmed.com
Phone514-631-7988
Emailinfo@surgmed.com

Device Dimensions

Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100690521009318 [Package]
Contains: 00690521013735
Package: Box [10 Units]
In Commercial Distribution
GS100690521013735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-06-05

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