Biosteon® Cross Pin 234-500-340

GUDID 15060155710355

The Biosteon® Cross Pin is a bioabsorbable HA/PLLA, for surgical reconstruction of anterior cruciate ligament (ACL) deficient knee to provide cross pi

BIOCOMPOSITES LTD

Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw
Primary Device ID15060155710355
NIH Device Record Key06c3e43b-760e-4355-8f54-07f4bfea22b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiosteon® Cross Pin
Version Model Number234-500-340
Catalog Number234-500-340
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

Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 Millimeter
Length40 Millimeter
Width6 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
GS115060155710355 [Primary]

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 Date2015-05-31

On-Brand Devices [Biosteon® Cross Pin]

15060155710362The Biosteon® Cross Pin is a bioabsorbable HA/PLLA, for surgical reconstruction of anterior cru
15060155710355The Biosteon® Cross Pin is a bioabsorbable HA/PLLA, for surgical reconstruction of anterior cru

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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