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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, non-antimicrobial FDA UDI
Model / Reference
00884450314074 FDA UDI

Identifiers

Catalog Number
4457/A FDA UDI
Primary DI / UDI-DI
00884450314074 FDA UDI
FDA Product Code
NDN FDA UDI
GMDN Term
Orthopaedic cement, non-antimicrobial 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic cement, non-antimicrobial

StabiliT StabiliT is a medical device designed for orthopedic cement applications. It's made from non-antimicrobial methylmethacrylate, providing a durable and long-lasting fixation of polymer or metallic implants to living bone. The device is typically used in vertebroplasty and kyphoplasty procedures for the treatment of vertebral body structures.

Similar devices

Also classified as Orthopaedic cement, non-antimicrobial.

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 098b0438-46d1-4820-a64c-7cad001d1291 33 fields · synced Jul 18, 2026