← Back to catalogue

Kyocera Medical Technologies, Inc.

FDA UDI

Class I (US FDA UDI)

by Kyocera Medical Technologies, Inc.

Identity

Trade Name
Kyocera Medical Technologies, Inc. FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Skyway, Plate Template - 14mm FDA UDI
Model / Reference
Skyway ACP FDA UDI
Description
Skyway, Plate Template - 14mm FDA UDI

Identifiers

Catalog Number
2061-003-214 FDA UDI
Primary DI / UDI-DI
00841523159673 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation 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: General internal orthopaedic fixation system implantation kit

Kyocera Medical Technologies, Inc. by Kyocera Medical Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kyocera Medical Technologies, Inc.

Sources (1)

  • FDA UDI 91427366-2948-48bd-a55b-d9dc7f3387da 34 fields · synced Jun 8, 2026