Injector TMI1162

GUDID M803TMI1162

EZ Inject HF SHG Catheter

MEDGYN PRODUCTS, INC.

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

• Primary Device ID: M803TMI1162
• NIH Device Record Key: 32b3ded0-2e94-45b9-9dbe-5b5f33e43a2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Injector
• Version Model Number: EZ Inject HF SHG Catheter
• Catalog Number: TMI1162
• 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	M803TMI1162 [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

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