DEFINITY CERVICAL DILATOR, 5MM DCD-501

GUDID 35420045512416

Hologic, Inc.

Cervical dilatation catheter

• Primary Device ID: 35420045512416
• NIH Device Record Key: f91bd609-8472-4f5f-a606-95a0b06f941d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFINITY CERVICAL DILATOR, 5MM
• Version Model Number: DCD-501
• Catalog Number: DCD-501
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045512412 [Primary]
GS1	25420045512419 [Package]; Contains: 15420045512412; Package: BOX [5 Units]; In Commercial Distribution
GS1	25420045512440 [Package]; Contains: 15420045512412; Package: BOX [1 Units]; In Commercial Distribution
GS1	35420045512416 [Package]; Contains: 25420045512419; Package: BOX [5 Units]; In Commercial Distribution
GS1	35420045512447 [Package]; Contains: 25420045512440; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190813

FDA Product Code

• PON: Catheter, balloon, dilation of cervical canal

Sterilization

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

[35420045512416]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-13
• Device Publish Date: 2020-02-05

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