FRS™ SCREW P2020

GUDID 08426750013855

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID08426750013855
NIH Device Record Keye20f3b99-52e0-42fa-b182-2e1a59f4d1df
Commercial Distribution StatusIn Commercial Distribution
Brand NameFRS™ SCREW
Version Model NumberP2020
Catalog NumberP2020
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108426750013855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08426750013855]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2015-10-24

On-Brand Devices [FRS™ SCREW]

00887868115752P2016
00887868115745P2014
00887868115738P2012
00887868115721P2010
00887868115677P1034
00887868115660P1032
00887868115653P1030
00887868115646P1028
00887868115639P1026
00887868115622P1024
08426750013886P2026
08426750013879P2024
08426750013862P2022
08426750013855P2020
08426750013848P2018

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