SteinerBio

GUDID 00860010170137

STEINER BIOTECHNOLOGY LLC.

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft
Primary Device ID00860010170137
NIH Device Record Keye7cd3276-f16e-4c44-9429-16840bba0e2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteinerBio
Version Model NumberSteinerBio Socket Graft Plus 1.0 cc
Company DUNS069907701
Company NameSTEINER BIOTECHNOLOGY LLC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010170137 [Primary]

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-01
Device Publish Date2023-04-21

On-Brand Devices [SteinerBio]

00860010170267SteinerBio OsseoConduct Micron
00860010170250SteinerBio OsseoConduct Macro Granules 1000-2000 m
00860010170243SteinerBio OsseoConduct Macro Granules 1000-2000 m
00860010170236SteinerBio OsseoConduct Standard Granules 500-1000
00860010170229SteinerBio OsseoConduct Standard Granules 500-1000
00860010170212SteinerBio OsseoConduct Perio Granules 250-500 mic
00860010170205SteinerBio OsseoConduct Perio Granules 250-500 mic
00860010170199SteinerBio Oral Bond
00860010170182SteinerBio Sinus Graft
00860010170175SteinerBio Ridge Graft Kit
00860010170168SteinerBio BioDensification
00860010170151SteinerBio Immediate Graft
00860010170144SteinerBio Socket Graft Injectable 1.0 cc
00860010170137SteinerBio Socket Graft Plus 1.0 cc
00860010170120SteinerBio Socket Graft Plus 0.5 cc
00860010170113SteinerBio Socket Graft 1.0 cc
00860010170106SteinerBio Socket Graft 0.5 cc

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