BioPro Bipolar Head 47mm

GUDID M209181390

BIOPRO, INC.

Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty
Primary Device IDM209181390
NIH Device Record Key1561841c-2d69-46e7-8e69-0c9075184a9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPro Bipolar Head 47mm
Version Model Number18139
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 Numbertrue
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
HIBCCM209181390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, Hip, Hemi-, Femoral, Metal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-09
Device Publish Date2015-09-16

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