FDA.reportPublic FDA data

Bespa Charcot System

Primary DI
00810041320001
Brand
Bespa Charcot System
Company
Kapstone Manufacturing, LLC
Model
BSP01-9-9000
Catalog number
BSP01-9-9000
Device description
Driver Handle, AO
Published
2023-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LRZScrewdriver, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041320001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041320001008100413200018100413200010810041320001

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
074092521
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810041320346Bespa Charcot SystemBSP01-1-1501BSP01-1-15012023-02-28
00810041320353Bespa Charcot SystemBSP01-1-1502-02BSP01-1-1502-022023-02-28
00810041320360Bespa Charcot SystemBSP01-1-1502-10BSP01-1-1502-102023-02-28
00810041320377Bespa Charcot SystemBSP01-1-1502-20BSP01-1-1502-202023-02-28
00810041320384Bespa Charcot SystemBSP01-1-1503BSP01-1-15032023-02-28
00810041320452Bespa Charcot SystemBSP01-1-1504BSP01-1-15042023-02-28
00810041320391Bespa Charcot SystemBSP01-1-1505-45BSP01-1-1505-452023-02-16
00810041320407Bespa Charcot SystemBSP01-1-1505-50BSP01-1-1505-502023-02-16
00810041320414Bespa Charcot SystemBSP01-1-1505-60BSP01-1-1505-602023-02-16
00810041320421Bespa Charcot SystemBSP01-1-1505-70BSP01-1-1505-702023-02-16
00810041320469Bespa Charcot SystemBSP01-1-1505-15BSP01-1-1505-152023-02-16
00810041320476Bespa Charcot SystemBSP01-1-1505-20BSP01-1-1505-202023-02-16
00810041320483Bespa Charcot SystemBSP01-1-1505-25BSP01-1-1505-252023-02-16
00810041320490Bespa Charcot SystemBSP01-1-1505-30BSP01-1-1505-302023-02-16
00810041320506Bespa Charcot SystemBSP01-1-1505-35BSP01-1-1505-352023-02-16
00810041320513Bespa Charcot SystemBSP01-1-1505-40BSP01-1-1505-402023-02-16
00810041320216Bespa Charcot SystemBSP01-6-1501-04BSP01-6-1501-042023-02-16
00810041320223Bespa Charcot SystemBSP01-6-1501-05BSP01-6-1501-052023-02-16
00810041320230Bespa Charcot SystemBSP01-2-1511BSP01-2-15112023-02-16
00810041320247Bespa Charcot SystemBSP01-6-1501-06BSP01-6-1501-062023-02-16

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Primary DI, Brand, Company table
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B8034803600ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803620ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
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