FDA.reportPublic FDA data

DynaNail Mini

Primary DI
M97026000080700
Brand
DynaNail Mini
Company
Medshape, Inc.
Model
2600-00-8070
Device description
DynaNail Mini, 8 mm x 70 mm
Published
2019-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDSNail, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDSNail, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M97026000080700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis nail, sterileA sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
601306413
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446907466EF1916-07-00012026-06-25
00190446907473EF1916-07-00022026-06-25
M97015000009200Eclipse1500-00-09202017-02-16
M97015000004100Eclipse1500-00-04102017-05-19
M97015000004170Eclipse1500-00-04172017-02-16
M97015000005120Eclipse1500-00-05122017-05-19
M97015000005200Eclipse1500-00-05202017-05-19
M97015000006200Eclipse1500-00-06202017-05-19
M97015000007200Eclipse1500-00-07202017-05-19
M97015000008200Eclipse1500-00-08202017-05-19
00190446914020EF1DNE-1000-WFB32026-04-01
00190446914563EF1DNE-6000-0402026-04-01
00190446907374EF1911-07-00012026-03-31
00190446907381EF1911-07-00022026-03-31
00190446907404EF1912-07-00012026-03-31
00190446907411EF1912-07-00022026-03-31
00190446908333EF1913-07-00012026-03-31
00190446908340EF1913-07-00022026-03-31
00190446908357EF1913-07-00032026-03-31
00190446908364EF1913-07-00042026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124526044FibFixFUSION ORTHOPEDICS, LLCJDS2026-09-25
00840124526051FibFixFUSION ORTHOPEDICS, LLCJDS2026-09-25
00840124526068FibFixFUSION ORTHOPEDICS, LLCJDS2026-09-25
00840124526075FibFixFUSION ORTHOPEDICS, LLCJDS2026-09-25
00193982471415AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471439AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471453AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471477AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471491AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471514AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471538AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471767AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471781AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471804AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471828AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471842AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471866AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471880AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472115AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472139AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472153AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472177AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472191AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472214AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472238AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473822AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473846AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473860AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473884AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473907AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14