CERVICAL SEAL ASSY DEVICE OLK-100

GUDID 15420045512191

Hologic, Inc.

Hysteroscopy cervical leakage sheath

• Primary Device ID: 15420045512191
• NIH Device Record Key: c6c8ae82-f032-4589-acfc-9d3edf180c11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERVICAL SEAL ASSY DEVICE
• Version Model Number: OLK-100
• Catalog Number: OLK-100
• 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

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045512191 [Primary]
GS1	25420045512198 [Package]; Package: BOX [5 Units]; In Commercial Distribution
GS1	35420045512195 [Package]; Contains: 25420045512198; Package: BOX [5 Units]; In Commercial Distribution
GS1	45420045512192 [Package]; Contains: 35420045512195; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191281

FDA Product Code

• QHZ: Seal, cervical, mechanical, unpowered

Sterilization

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

[15420045512191]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-19
• Device Publish Date: 2019-09-11

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• 15420045517073 - Aptima®: 2024-12-27 Aptima® CV/TV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificatio
• 15420045517080 - Aptima®: 2024-12-27 Aptima® CV/TV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificat
• 15420045506411 - ATEC: 2024-10-24
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