DynaNail Hybrid

GUDID M97026010071400

DynaNail Hybrid, 7mm x 140mm

Medshape, Inc.

Arthrodesis nail
Primary Device IDM97026010071400
NIH Device Record Key8b5d9763-1297-4e82-a031-042e1567d038
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaNail Hybrid
Version Model Number2601-00-7140
Company DUNS601306413
Company NameMedshape, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM97026010071400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-12-08
Device Publish Date2021-04-23

On-Brand Devices [DynaNail Hybrid]

M97026010071300DynaNail Hybrid, 7mm x 130mm
M97026010071200DynaNail Hybrid, 7mm x 120mm
M97026010071100DynaNail Hybrid, 7mm x 110mm
M97026010071000DynaNail Hybrid, 7mm x 100mm
M97026010070900DynaNail Hybrid, 7mm x 90mm
M97026010070800DynaNail Hybrid, 7mm x 80mm
M97026010070700DynaNail Hybrid, 7mm x 70mm
M97026010070600DynaNail Hybrid, 7mm x 60mm
M97026010071400DynaNail Hybrid, 7mm x 140mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.