BIOSORB - BIO1-S B1S2692224

GUDID 03760154002189

Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)

S.B.M

Synthetic bone graft

• Primary Device ID: 03760154002189
• NIH Device Record Key: b5177f1d-e012-4c6b-bdc7-2ddd4634614c
• Commercial Distribution Discontinuation: 2020-01-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIOSORB - BIO1-S
• Version Model Number: BIO1-S with Ø 0.6 mm granules
• Catalog Number: B1S2692224
• 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: 1 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154002189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071155

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: 2015-10-16

On-Brand Devices [BIOSORB - BIO1-S]

• 03760154001656: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154001649: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154001632: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154001625: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154001618: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154001601: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154002196: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154002189: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154002172: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
• 03760154002165: Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)