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Natrelle INSPIRA Resterilizable Sizers

FDA UDI

Class U (US FDA UDI)

by Allergan

Identity

Trade Name
Natrelle INSPIRA Resterilizable Sizers FDA UDI
Generic Name
Invasive breast implant sizer, fixed, reusable FDA UDI
Device Name
NATRELLE INSPIRA Rester Szr Sty MSZ-M445 Moderate FDA UDI
Model / Reference
MSZ-M445 FDA UDI
Description
NATRELLE INSPIRA Rester Szr Sty MSZ-M445 Moderate FDA UDI

Identifiers

Catalog Number
MSZ-M445 FDA UDI
Primary DI / UDI-DI
10888628009141 FDA UDI
510(k) Number
K831566 FDA UDI
FDA Product Code
MRD FDA UDI
GMDN Term
Invasive breast implant sizer, fixed, reusable FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Invasive breast implant sizer, fixed, reusable

Natrelle INSPIRA Resterilizable Sizers by Allergan — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Invasive breast implant sizer, fixed, reusable.

Cleared under the same submission

K831566 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allergan

Sources (1)

  • FDA UDI 579d1b1a-6677-41e9-995a-4950dd565dd9 37 fields · synced May 30, 2026