Biofiber™ - CM
GUDID 00846832010509
TORNIER, INC.
Multi-purpose surgical mesh, synthetic polymer, bioabsorbable| 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 |
Customer Support Contacts
Device Dimensions
| 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 |
| 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 |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832010509 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111337
FDA Product Code
| FTL | Mesh, surgical, polymeric |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-16 |
Devices Manufactured by TORNIER, INC.
| 00840338603685 - Tornier HRS Max | 2025-11-26 Bone Clamp |
| 00840338603692 - Tornier HRS Max | 2025-11-26 Saw Guide |
| 00840338603708 - Tornier HRS Max | 2025-11-26 Drop Rod |
| 00840338603821 - Tornier HRS Max | 2025-11-26 Expanding Trial |
| 00840338603838 - Tornier HRS Max | 2025-11-26 Expanding Trial |
| 00840338603845 - Tornier HRS Max | 2025-11-26 Expanding Trial |
| 00840338603852 - Tornier HRS Max | 2025-11-26 Expanding Trial |
| 00840338603869 - Tornier HRS Max | 2025-11-26 Expanding Trial |
Trademark Results [Biofiber]
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 |
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