Orthopediatrics Instrumentation

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: Orthopediatrics Instrumentation FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: 1.6mm Mini Tack, 35mm, Smooth FDA UDI
Model / Reference: 01-1007-0932 FDA UDI
Description: 1.6mm Mini Tack, 35mm, Smooth FDA UDI

Identifiers

Catalog Number: 01-1007-0932 FDA UDI
Primary DI / UDI-DI: 00841132174364 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Orthopaedic guidewire, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic guidewire, single-use

Orthopediatrics Instrumentation by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM — Orthopediatrics Canada ULC · Class I
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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Corp.

Sources (1)

FDA UDI f66b8796-4b9c-4105-a24e-91d05aa84d06 35 fields · synced May 30, 2026