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Bespa Charcot System

FDA UDI

Class II (US FDA UDI)

by Kapstone Manufacturing

Identity

Trade Name
Bespa Charcot System FDA UDI
Generic Name
Arthrodesis intramedullary nail, non-distracting FDA UDI
Device Name
Seg Column, Middle, no hole, 10 FDA UDI
Model / Reference
BSP01-1-1502-10 FDA UDI
Description
Seg Column, Middle, no hole, 10 FDA UDI

Identifiers

Catalog Number
BSP01-1-1502-10 FDA UDI
Primary DI / UDI-DI
00810041320360 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Arthrodesis intramedullary nail, non-distracting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Arthrodesis intramedullary nail, non-distracting

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

Similar devices

Also classified as Arthrodesis intramedullary nail, non-distracting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9c147b6b-f57e-4c53-a9a7-4d89ceb49ba8 34 fields · synced May 30, 2026