BIOSORB - BIO1-S B1S2692244

GUDID 03760154001625

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

S.B.M

Synthetic bone graft
Primary Device ID03760154001625
NIH Device Record Keye9ec084d-01a7-4df9-9f26-3ccfbf76e523
Commercial Distribution Discontinuation2020-01-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBIOSORB - BIO1-S
Version Model NumberBIO1-S with Ø 1 mm granules
Catalog NumberB1S2692244
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 Volume1 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS103760154001625 [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 Number5
Public Version Date2020-01-10
Device Publish Date2015-10-16

On-Brand Devices [BIOSORB - BIO1-S]

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

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