HBS SCREW 2.5 X 32MM SDST

GUDID 00810012484794

BIOPRO, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00810012484794
NIH Device Record Key7541cc61-5632-413c-bee5-45869da3d0ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameHBS SCREW 2.5 X 32MM SDST
Version Model Number20511
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
GS100810012484794 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-13
Device Publish Date2019-06-05

Devices Manufactured by BIOPRO, INC.

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