Sizer Set

FDA UDI

Class I (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: Sizer Set FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: Sizer Set FDA UDI
Model / Reference: ASY-16190 FDA UDI
Description: Sizer Set FDA UDI

Identifiers

Catalog Number: F0101 FDA UDI
Primary DI / UDI-DI: 15420045515390 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

Sizer Set by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hologic, Inc.

Sources (1)

FDA UDI 4c58a7c8-2c2b-4188-9f97-0b8ab88f37b8 35 fields · synced Jun 8, 2026