PliaFX Flo BL-2225-00

GUDID 00889858640855

PliaFX Flo Flowable Demineralized Fibers, 0.5cc

LIFENET HEALTH

Bone matrix implant, human-derived
Primary Device ID00889858640855
NIH Device Record Key812cfd0b-3c8d-4bfd-b7cd-7caa12ce28dd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePliaFX Flo
Version Model NumberBL-2225-00
Catalog NumberBL-2225-00
Company DUNS121828156
Company NameLIFENET HEALTH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889858640855 [Primary]

FDA Product Code

MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-09
Device Publish Date2025-01-01

On-Brand Devices [PliaFX Flo]

00889858640893PliaFX Flo Flowable Demineralized Fibers, 10cc
00889858640886PliaFX Flo Flowable Demineralized Fibers, 5cc
00889858640879PliaFX Flo Flowable Demineralized Fibers, 2.5cc
00889858640862PliaFX Flo Flowable Demineralized Fibers, 1cc
00889858640855PliaFX Flo Flowable Demineralized Fibers, 0.5cc
00889858640848PliaFX Flo Flowable Demineralized Fibers
00889858640831PliaFX Flo Flowable Demineralized Fibers, 5cc
00889858640824PliaFX Flo Flowable Demineralized Fibers, 2.5cc
00889858640817PliaFX Flo Flowable Demineralized Fibers, 1cc
00889858640800PliaFX Flo Flowable Demineralized Fibers, 0.5cc

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