MedGyn Disposable Amnio Hook 020301

GUDID M803020301

MedGyn Disposable Amnio Hook

MEDGYN PRODUCTS, INC.

Amniotome, single-use

• Primary Device ID: M803020301
• NIH Device Record Key: 79e010ea-28e4-4eb6-8d80-def739caf821
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedGyn Disposable Amnio Hook
• Version Model Number: Amniotome
• Catalog Number: 020301
• Company DUNS: 103913430
• Company Name: MEDGYN PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	M803020301 [Primary]

FDA Product Code

• HGE: Amniotome

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: 2024-05-08
• Device Publish Date: 2024-04-30

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