Solum Flow 1206-0050

GUDID 00817771028818

Celling Biosciences

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 ID00817771028818
NIH Device Record Key07fe825f-ffb6-4eb8-9e12-1ae4d5de9cb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolum Flow
Version Model NumberSolum Flow - 5cc
Catalog Number1206-0050
Company DUNS021560394
Company NameCelling Biosciences
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 Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817771028818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-11
Device Publish Date2022-11-03

On-Brand Devices [Solum Flow]

00817371020632Solum Flow - 5cc
00817371020625Solum Flow - 2cc
00817771028818Solum Flow - 5cc
00817771028801Solum Flow - 2cc

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