BIO1-KIT SER2692650

GUDID 03760154004916

Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe

S.B.M

Synthetic bone graft
Primary Device ID03760154004916
NIH Device Record Keyb963a300-2911-486f-b1f5-e8cc9eac4b6e
Commercial Distribution Discontinuation2020-01-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBIO1-KIT
Version Model NumberBIO1-KIT pre-loaded syringe with Ø3 mm granules
Catalog NumberSER2692650
Company DUNS772462123
Company NameS.B.M
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-369-1782
Emailgboue@s-b-m.us

Device Dimensions

Total Volume45 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS103760154004916 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-10
Device Publish Date2015-10-13

On-Brand Devices [BIO1-KIT ]

03760154004978Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004961Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004954Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004947Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004930Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004923Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004916Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004909Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004893Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004886Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004879Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004862Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004855Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004848Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe
03760154004817Absorbable calcium salt (BIOSORB) bone void filler pre-loaded in bone graft delivery syringe

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