Biofiber™ - CM

GUDID 00846832010509

TORNIER, INC.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID00846832010509
NIH Device Record Key2e31b94f-38db-441f-b394-11f8241bfce5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiofiber™ - CM
Version Model NumberBFR100302
Company DUNS968990812
Company NameTORNIER, INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com

Device Dimensions

Width20 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter
Length30 Millimeter
Width20 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832010509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, surgical, polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-16

Devices Manufactured by TORNIER, INC.

00840338602824 - Tornier HRS2024-12-25 Hex Driver
00840338602831 - Tornier HRS2024-12-25 Instrument Case Base
00840338602848 - Tornier Perform Humeral System2024-12-25 Reverse Insert Trials Base
00840338602855 - Tornier HRS2024-12-25 Instrument Case Lid
00840338602862 - Tornier Perform Humeral System2024-12-25 Reverse Insert Trials Lid
00840338602893 - Tornier HRS2024-12-25 Instrument Inner Tray
00840338603173 - Tornier Perform Humeral System2024-12-25 Reversed Insert Trial, 65%
00840338603180 - Tornier Perform Humeral System2024-12-25 Reversed Insert Trial, 65%

Trademark Results [Biofiber]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOFIBER
BIOFIBER
98605230 not registered Live/Pending
KADANT LAMORT
2024-06-17
BIOFIBER
BIOFIBER
85699599 not registered Dead/Abandoned
GSB of DC, Inc.
2012-08-09
BIOFIBER
BIOFIBER
79263605 not registered Live/Pending
Biofiber Tech Sweden AB
2019-03-21
BIOFIBER
BIOFIBER
77550091 3694356 Live/Registered
Tornier, Inc.
2008-08-19
BIOFIBER
BIOFIBER
77422927 not registered Dead/Abandoned
Bruce Wright
2008-03-14
BIOFIBER
BIOFIBER
77343741 not registered Dead/Abandoned
Master Supplements, Inc.
2007-12-04
BIOFIBER
BIOFIBER
76537652 not registered Dead/Abandoned
BIOFIBER-DAMINO A/S
2003-08-11
BIOFIBER
BIOFIBER
75911877 not registered Dead/Abandoned
BioSensor, Inc.
2000-02-08
BIOFIBER
BIOFIBER
75615986 2399153 Dead/Cancelled
MKT Community Development, Inc.
1999-01-05

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