MTP FUSION PLATE, NARROW 10 DEGREE, RIGHT

GUDID M20923084

BIOPRO, INC.

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable
Primary Device IDM20923084
NIH Device Record Key29771c42-5619-4bff-8823-ae2bff444b12
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTP FUSION PLATE, NARROW 10 DEGREE, RIGHT
Version Model Number23084
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
HIBCCM20923084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


[M20923084]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-03
Device Publish Date2024-03-26

Devices Manufactured by BIOPRO, INC.

M209230790 - MTP FUSION PLATE 5 DEGREE, LEFT2024-04-03
M209230800 - MTP FUSION PLATE 5 DEGREE, RIGHT2024-04-03
M209230810 - MTP FUSION PLATE 0 DEGREE, LEFT2024-04-03
M209230820 - MTP FUSION PLATE 0 DEGREE, RIGHT2024-04-03
M209230830 - MTP FUSION PLATE, NARROW 10 DEGREE, LEFT2024-04-03
M20923084 - MTP FUSION PLATE, NARROW 10 DEGREE, RIGHT2024-04-03
M20923084 - MTP FUSION PLATE, NARROW 10 DEGREE, RIGHT2024-04-03
M20923085 - MTP FUSION PLATE, NARROW 5 DEGREE, LEFT2024-04-03
M209230860 - MTP FUSION PLATE, NARROW 5 DEGREE, RIGHT2024-04-03

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