BIO1-KIT SER2692444

GUDID 03760154004978

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

S.B.M

Synthetic bone graft

• Primary Device ID: 03760154004978
• NIH Device Record Key: 52c5979f-0842-4083-9a2c-3c641e9c0213
• Commercial Distribution Discontinuation: 2020-01-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIO1-KIT
• Version Model Number: BIO1-KIT pre-loaded syringe with Ø1.5 mm granules
• Catalog Number: SER2692444
• Company DUNS: 772462123
• Company Name: S.B.M
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-369-1782
• Email: gboue@s-b-m.us

Device Dimensions

• Total Volume: 10 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154004978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061022

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-10
• Device Publish Date: 2015-10-13

On-Brand Devices [BIO1-KIT ]

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