14MM FUSION NAIL, LEFT

GUDID M209215950

BIOPRO, INC.

Arthrodesis nail, sterile
Primary Device IDM209215950
NIH Device Record Keyf82b4ea2-bb7a-47c8-9b3d-ef2d99b90cf3
Commercial Distribution StatusIn Commercial Distribution
Brand Name14MM FUSION NAIL, LEFT
Version Model Number21595
Company DUNS618749857
Company NameBIOPRO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
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
HIBCCM209215950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-20
Device Publish Date2019-06-12

On-Brand Devices [14MM FUSION NAIL, LEFT ]

M20921595021595
M20921587021587

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