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Proview

FDA UDI

Class I (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name
PROVIEW FDA UDI
Generic Name
Growth-correction orthopaedic fixation plate kit FDA UDI
Device Name
DILATOR #10, .375 OD, .250 ID MIS FDA UDI
Model / Reference
70-2010 FDA UDI
Description
DILATOR #10, .375 OD, .250 ID MIS FDA UDI

Identifiers

Primary DI / UDI-DI
18257200066124 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Growth-correction orthopaedic fixation plate kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Growth-correction orthopaedic fixation plate kit

Proview by Orthofix US LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Growth-correction orthopaedic fixation plate kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthofix US LLC

Sources (1)

  • FDA UDI 0d8cd8f2-3fc0-4358-ba04-79b82e21d1ca 34 fields · synced May 29, 2026