Biosteon® IntraLine® 3910-200-085

GUDID 35060155711202

The Biosteon® IntraLine® 6.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite

BIOCOMPOSITES LTD

Orthopaedic bone screw, bioabsorbable
Primary Device ID35060155711202
NIH Device Record Keyfe639555-d133-4c7e-998f-e4ae523d13c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiosteon® IntraLine®
Version Model Number3910-200-085
Catalog Number3910-200-085
Company DUNS424382307
Company NameBIOCOMPOSITES LTD
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com

Device Dimensions

Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter
Width6.5 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115060155711208 [Primary]
GS135060155711202 [Package]
Contains: 15060155711208
Package: Sleeve [5 Units]
In Commercial Distribution

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-06-30

On-Brand Devices [Biosteon® IntraLine®]

15060155711215The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single
35060155711202The Biosteon® IntraLine® 6.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a s
15060155711192The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single us
15060155711185The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single
15060155711178The Biosteon® IntraLine® 5.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a s
35060155711165The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single us

Trademark Results [Biosteon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOSTEON
BIOSTEON
76266609 2648714 Live/Registered
Biocomposites Ltd
2001-06-04

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