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CarboJet XF® Bone Preparation System

FDA UDI

Class II (US FDA UDI)

by Kinamed, Inc.

Identity

Trade Name
CarboJet XF® Bone Preparation System FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Handpiece Set with 40° Nozzle FDA UDI
Model / Reference
27-100-1000 FDA UDI
Description
Handpiece Set with 40° Nozzle FDA UDI

Identifiers

Catalog Number
27-100-1000 FDA UDI
Primary DI / UDI-DI
00818720012414 FDA UDI
FDA Product Code
FQH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

CarboJet XF® Bone Preparation System by Kinamed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kinamed, Inc.

Sources (1)

  • FDA UDI 5984f1ee-8823-40f7-b037-95116e55bd5f 34 fields · synced May 30, 2026