BIOPRO MEMORY STAPLE 15X15-1.5X1.5MM PKG

GUDID M209227750

BIOPRO MEMORY STAPLE 15X15-1.5X1.5MM PKG

BIOPRO, INC.

Orthopaedic bone staple, non-adjustable
Primary Device IDM209227750
NIH Device Record Keyc40b2005-70d1-43d2-ad8c-ddc24a7b9162
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOPRO MEMORY STAPLE 15X15-1.5X1.5MM PKG
Version Model Number22775
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM209227750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-23
Device Publish Date2020-06-01

Devices Manufactured by BIOPRO, INC.

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M209178060 - THUMB MOD HEAD TITANIUM 14MM2024-07-08
M209178070 - THUMB MOD HEAD TITANIUM 14MM+22024-07-08
M209178080 - THUMB MOD HEAD TITANIUM 15MM2024-07-08
M209178090 - THUMB MOD HEAD TITANIUM 15MM+22024-07-08
M209177980 - THUMB MOD HEAD TITANIUM 13MM2024-06-07

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