HSG Kits TMI1157

GUDID M803TMI1157

HSG tray

MEDGYN PRODUCTS, INC.

Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector

• Primary Device ID: M803TMI1157
• NIH Device Record Key: 4df48a7a-739b-454c-a812-54a4befc7dee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HSG Kits
• Version Model Number: HSG tray
• Catalog Number: TMI1157
• Company DUNS: 103913430
• Company Name: MEDGYN PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M803TMI1157 [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: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [HSG Kits]

• M803TMI1199: HSG tray with Shapeable 7F HS
• M803TMI1198: HSG tray with Shapeable 5F HS
• M803TMI1161: HSG tray with 7F HS
• M803TMI1160: HSG tray with 5F HS
• M803TMI1157: HSG tray