HBS (STERILE) COMPLETE KIT

GUDID 00810012484251

BIOPRO, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00810012484251
NIH Device Record Keyf1ea9897-ff34-4606-9e74-79d62a8b3e78
Commercial Distribution StatusIn Commercial Distribution
Brand NameHBS (STERILE) COMPLETE KIT
Version Model Number19686
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
GS100810012484251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-14
Device Publish Date2019-06-06

Devices Manufactured by BIOPRO, INC.

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M209178080 - THUMB MOD HEAD TITANIUM 15MM2024-07-08
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M209177980 - THUMB MOD HEAD TITANIUM 13MM2024-06-07

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