HBS 2.5MM SCREW 1.68MM DRILL STERILE

GUDID 00810012482417

BIOPRO, INC.

Surgical drill guide, single-use
Primary Device ID00810012482417
NIH Device Record Keybb3e221a-ef64-4e26-989c-e80c0859e23e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHBS 2.5MM SCREW 1.68MM DRILL STERILE
Version Model Number19684
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
GS100810012482417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXIGuide, Drill, Ligament

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-09
Device Publish Date2019-06-06

Devices Manufactured by BIOPRO, INC.

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