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StabiliT®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
StabiliT® FDA UDI
Generic Name
Orthopaedic cement preparation/delivery kit FDA UDI
Model / Reference
00884450325766 FDA UDI

Identifiers

Catalog Number
MX-1100S-01/B FDA UDI
Primary DI / UDI-DI
00884450325766 FDA UDI
FDA Product Code
NDN FDA UDI
GMDN Term
Orthopaedic cement preparation/delivery kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3027 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic cement preparation/delivery kit

The StabiliT Orthopaedic Cement Preparation/Delivery Kit is a single-use, sterile collection of instruments and materials designed to prepare and apply bone cement during orthopaedic surgical procedures. This device is typically included with implantable devices, such as hip replacements or vertebroplasties, but can also be used for non-implantable procedures.

Similar devices

Also classified as Orthopaedic cement preparation/delivery kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 8b5524ca-7e08-41ed-8726-e4ee10fc27d4 34 fields · synced Jul 15, 2026