Primary Device ID | 00846832010509 |
NIH Device Record Key | 2e31b94f-38db-441f-b394-11f8241bfce5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Biofiber™ - CM |
Version Model Number | BFR100302 |
Company DUNS | 968990812 |
Company Name | TORNIER, INC. |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Width | 20 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Length | 30 Millimeter |
Width | 20 Millimeter |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00846832010509 [Primary] |
FTL | Mesh, surgical, polymeric |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-10-16 |
00840338602824 - Tornier HRS | 2024-12-25 Hex Driver |
00840338602831 - Tornier HRS | 2024-12-25 Instrument Case Base |
00840338602848 - Tornier Perform Humeral System | 2024-12-25 Reverse Insert Trials Base |
00840338602855 - Tornier HRS | 2024-12-25 Instrument Case Lid |
00840338602862 - Tornier Perform Humeral System | 2024-12-25 Reverse Insert Trials Lid |
00840338602893 - Tornier HRS | 2024-12-25 Instrument Inner Tray |
00840338603173 - Tornier Perform Humeral System | 2024-12-25 Reversed Insert Trial, 65% |
00840338603180 - Tornier Perform Humeral System | 2024-12-25 Reversed Insert Trial, 65% |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIOFIBER 98605230 not registered Live/Pending |
KADANT LAMORT 2024-06-17 |
BIOFIBER 85699599 not registered Dead/Abandoned |
GSB of DC, Inc. 2012-08-09 |
BIOFIBER 79263605 not registered Live/Pending |
Biofiber Tech Sweden AB 2019-03-21 |
BIOFIBER 77550091 3694356 Live/Registered |
Tornier, Inc. 2008-08-19 |
BIOFIBER 77422927 not registered Dead/Abandoned |
Bruce Wright 2008-03-14 |
BIOFIBER 77343741 not registered Dead/Abandoned |
Master Supplements, Inc. 2007-12-04 |
BIOFIBER 76537652 not registered Dead/Abandoned |
BIOFIBER-DAMINO A/S 2003-08-11 |
BIOFIBER 75911877 not registered Dead/Abandoned |
BioSensor, Inc. 2000-02-08 |
BIOFIBER 75615986 2399153 Dead/Cancelled |
MKT Community Development, Inc. 1999-01-05 |