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Kalitec Universal Instruments

FDA UDI

Class I (US FDA UDI)

by Kalitec Direct LLC

Identity

Trade Name
Kalitec Universal Instruments FDA UDI
Generic Name
Orthopaedic implant/instrument assembling device FDA UDI
Device Name
Tube, Guidewire, 520MM FDA UDI
Model / Reference
01-K12-8452 FDA UDI
Description
Tube, Guidewire, 520MM FDA UDI

Identifiers

Catalog Number
01-K12-8452 FDA UDI
Primary DI / UDI-DI
B07301K1284520 FDA UDI
FDA Product Code
HXI FDA UDI
GMDN Term
Orthopaedic implant/instrument assembling device 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: Orthopaedic implant/instrument assembling device

Kalitec Universal Instruments by Kalitec Direct LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant/instrument assembling device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kalitec Direct LLC

Sources (1)

  • FDA UDI d2d7e0bd-4246-4b1d-b00b-159576838dca 34 fields · synced May 30, 2026