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 Intrauterine imaging medium catheter

• Primary Device ID: 00690521009318
• NIH Device Record Key: 60ba6aa4-d6c0-406e-8756-c9d061c7b584
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Batrik H/S Catheter TM 5F
• Version Model Number: 51-5005
• Catalog Number: 51-5005
• Company DUNS: 243880700
• Company Name: Batrik Medical Manufacturing Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 514-631-7988
• Email: info@surgmed.com
• Phone: 514-631-7988
• Email: info@surgmed.com

Device Dimensions

• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690521009318 [Package]; Contains: 00690521013735; Package: Box [10 Units]; In Commercial Distribution
GS1	00690521013735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032835

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-05

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