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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
00884450296509 FDA UDI

Identifiers

Catalog Number
MX-2100S-01/A FDA UDI
Primary DI / UDI-DI
00884450296509 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 is a single-use, sterile orthopaedic cement preparation/delivery kit designed to facilitate effective bone cement delivery during surgical procedures. This device features a unique combination of tools and materials, including forceps, mallets, and mixing devices, making it an essential asset for orthopedic surgeons and medical professionals.

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 fb049df7-3d4d-43f6-bf6d-4c52b4bcab9a 34 fields · synced Jul 18, 2026