FDA.report

Bespa Charcot System

Primary DI
00810041320759
Brand
Bespa Charcot System
Company
Kapstone Manufacturing, LLC
Model
BSP01-9-2012
Catalog number
BSP01-9-2012
Device description
Steinmann Pins Smooth Single Trocar round end 12" 5/64”
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810041320759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041320759008100413207598100413207590810041320759

GMDN Terms

TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
074092521
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810041320179Bespa Charcot SystemBSP01-2-1506BSP01-2-15062023-02-28
00810041320186Bespa Charcot SystemBSP01-2-1507BSP01-2-15072023-02-28
00810041320278Bespa Charcot SystemBSP01-2-1508BSP01-2-15082023-02-28
00810041320292Bespa Charcot SystemBSP01-2-1509BSP01-2-15092023-02-28
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
00810041320742Bespa Charcot SystemBSP01-3-10002023-02-28
00810041320001Bespa Charcot SystemBSP01-9-9000BSP01-9-90002023-02-16
00810041320193Bespa Charcot SystemBSP01-2-1505BSP01-2-15052023-02-16
00810041320209Bespa Charcot SystemBSP01-2-1513BSP01-2-15132023-02-16
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
00810041320254Bespa Charcot SystemBSP01-6-1501-02BSP01-6-1501-022023-02-16
00810041320261Bespa Charcot SystemBSP01-2-1502BSP01-2-15022023-02-16

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