Dakota Knife Blade® 11-0204-FD2

GUDID M364110204FD20

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

MEDICAL DESIGNS LLC

Scalpel blade, single-use Scalpel blade, single-use Scalpel blade, single-use Scalpel blade, single-use Scalpel blade, single-use
Primary Device IDM364110204FD20
NIH Device Record Key2137e366-aaab-45bc-944b-81b731c6139c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDakota Knife Blade®
Version Model Number11-0204-FD2
Catalog Number11-0204-FD2
Company DUNS003815548
Company NameMEDICAL DESIGNS LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCC1102042 [Direct Marking]
HIBCC1102042 [Direct Marking]
HIBCC1102042 [Direct Marking]
HIBCC1102042 [Direct Marking]
HIBCC1102042 [Direct Marking]
HIBCCM364110204FD20 [Primary]
HIBCCM364110204FD20 [Primary]
HIBCCM364110204FD20 [Primary]
HIBCCM364110204FD20 [Primary]
HIBCCM364110204FD20 [Primary]

FDA Product Code

GDZHandle, Scalpel
GDZHandle, Scalpel
GDZHandle, Scalpel
GDZHandle, Scalpel
GDZHandle, Scalpel

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-11-06
Device Publish Date2016-09-27

Devices Manufactured by MEDICAL DESIGNS LLC

M364110204FD20 - Dakota Knife Blade®2020-11-06The 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
M364110204FD20 - Dakota Knife Blade®2020-11-06 The Dakota Knife® Blade is a stainless steel surgical instrument designed for use in open, limited open, and minimally invasive
11110629 - Asfora Anterior Cervical Plate System2020-04-06 Variable Angle Drill Guide
11110641 - Asfora Anterior Cervical Plate System2020-04-06 Fixed Angle Drill Guide
M364119902FD10 - Asfora Bullet Cage® System 2020-02-24 10mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenera
11990210 - Asfora Bullet Cage® System 2020-02-24 18mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenera
1199022 - Asfora Bullet Cage® System 2020-02-24 10mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenera
1199023 - Asfora Bullet Cage® System 2020-02-24 12mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenera
1199024 - Asfora Bullet Cage® System 2020-02-24 12mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenera

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.