FDA.reportPublic FDA data

Dakota Knife Blade®

Primary DI
M364110204FD20
Brand
Dakota Knife Blade®
Company
MEDICAL DESIGNS LLC
Model
11-0204-FD2
Catalog number
11-0204-FD2
Device description
The Dakota Knife® Blade is a stainless steel surgical instrument designed for use in open, limited open, and minimally invasive carpal tunnel release surgery. The Dakota Knife® Blade is a single-use, disposable cutting instrument for transecting the transverse carpal ligament
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
1102042Direct MarkingHIBCC0
M364110204FD20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel blade, single-useAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
605-275-1032kspielman@medicaldesignsllc.com

Regulatory Flags#

DUNS number
003815548
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M364111106FD1220Asfora Anterior Cervical Plate System11-1106-FD1-222016-09-27
M364111106FD1240Asfora Anterior Cervical Plate System11-1106-FD1-242016-09-27
M364111106FD1260Asfora Anterior Cervical Plate System11-1106-FD1-262016-09-27
M364111106FD1280Asfora Anterior Cervical Plate System11-1106-FD1-282016-09-27
M364111106FD1300Asfora Anterior Cervical Plate System11-1106-FD1-302016-09-27
M364111106FD1320Asfora Anterior Cervical Plate System11-1106-FD1-322016-09-27
M364111106FD1340Asfora Anterior Cervical Plate System11-1106-FD1-342016-09-27
M364111106FD2320Asfora Anterior Cervical Plate System11-1106-FD2-322016-09-27
M364111106FD2350Asfora Anterior Cervical Plate System11-1106-FD2-352016-09-27
M364111106FD2380Asfora Anterior Cervical Plate System11-1106-FD2-382016-09-27
M364111106FD2410Asfora Anterior Cervical Plate System11-1106-FD2-412016-09-27
M364111106FD2440Asfora Anterior Cervical Plate System11-1106-FD2-442016-09-27
M364111106FD2470Asfora Anterior Cervical Plate System11-1106-FD2-472016-09-27
M364111106FD2500Asfora Anterior Cervical Plate System11-1106-FD2-502016-09-27
M364111106FD350Asfora Anterior Cervical Plate System11-1106-FD352016-09-27
M364111106FD3510Asfora Anterior Cervical Plate System11-1106-FD3-512016-09-27
M364111106FD3540Asfora Anterior Cervical Plate System11-1106-FD3-542016-09-27
M364111106FD3570Asfora Anterior Cervical Plate System11-1106-FD3-572016-09-27
M364111106FD3600Asfora Anterior Cervical Plate System11-1106-FD3-602016-09-27
M364111106FD3630Asfora Anterior Cervical Plate System11-1106-FD3-632016-09-27

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Primary DI, Brand, Company table
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00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
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00810055255825Surgical DesignSurgical Design, Inc.GDZ2026-06-26
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00810055256105Surgical DesignSurgical Design, Inc.GDZ2026-06-26
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00810055256136Surgical DesignSurgical Design, Inc.GDZ2026-06-26
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00810055256174Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256181Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256198Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256204Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810189455139Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00190776421847MillenniumAvalign Technologies, Inc.GDZ2026-06-25
00810055257348Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257355Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257362Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257379Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257386Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257850Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05
00190776419769MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419776MillenniumAvalign Technologies, Inc.GDZ2026-04-15