Sizer Set F0101

GUDID 15420045515390

Hologic, Inc.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 15420045515390
• NIH Device Record Key: 4c58a7c8-2c2b-4188-9f97-0b8ab88f37b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sizer Set
• Version Model Number: F0101
• Catalog Number: F0101
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	15420045515390 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[15420045515390]

Moist Heat or Steam Sterilization

[15420045515390]

Moist Heat or Steam Sterilization

[15420045515390]

Moist Heat or Steam Sterilization

[15420045515390]

Moist Heat or Steam Sterilization

[15420045515390]

Moist Heat or Steam Sterilization

[15420045515390]

Moist Heat or Steam Sterilization

[15420045515390]

Moist Heat or Steam Sterilization

[15420045515390]

Moist Heat or Steam Sterilization

[15420045515390]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

Devices Manufactured by Hologic, Inc.

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• 15420045511453 - Panther Fusion®: 2024-04-15 Epstein-Barr virus (EBV) Probe ASR.
• 15420045511552 - Panther Fusion®: 2024-04-15 Hologic GAS Plasmid Control.
• 15420045511576 - Panther Fusion®: 2024-04-15 Group A Strep (GAS) Probe ASR.
• 15420045511590 - Panther Fusion®: 2024-04-15 Group A Strep (GAS) Primers ASR.
• 15420045512122 - Panther Fusion®: 2024-04-15 Hologic EBV Plasmid Control.
• 15420045515529 - OMNI: 2024-02-27 The Omni Hysteroscopic Scissors are sterile, single-use, hand actuated hysteroscopic scissors that are intended to be used by a