Bespa Charcot System

FDA UDI

Class I (US FDA UDI)

by Kapstone Manufacturing

Identity

Trade Name: Bespa Charcot System FDA UDI
Generic Name: Manual surgical rotary handpiece, reusable FDA UDI
Device Name: Segmental Column Driver FDA UDI
Model / Reference: BSP01-2-1502 FDA UDI
Description: Segmental Column Driver FDA UDI

Identifiers

Catalog Number: BSP01-2-1502 FDA UDI
Primary DI / UDI-DI: 00810041320261 FDA UDI
FDA Product Code: HXX FDA UDI
GMDN Term: Manual surgical rotary handpiece, reusable 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual surgical rotary handpiece, reusable

Bespa Charcot System by Kapstone Manufacturing — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Manual surgical rotary handpiece, reusable.

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MANUAL HANDPIECE DRIVER, FITS LATCH CONNECT 1:1 RATIO — W.H. Holden, Inc. · Class I
Invivo — Philips DS North America LLC · Class II
GII — Medos International Sàrl · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
HNM Medical — HNM STAINLESS, LLC. · Class I
HALLMARK — Orthofix US LLC · Class I
CHESAPEAKE Stabilization System — K2M, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Kapstone Manufacturing

Sources (1)

FDA UDI 3e0c7cd3-88f2-40d0-bb69-80745ddcb023 34 fields · synced Jun 6, 2026