Fortilink®-L IBF System with TETRAfuse 3D Technology 65-L-TRL14-8
GUDID 00846468086732
Fortilink-L IBF System Trial, 14mm (W) x 8mm (H)
Pioneer Surgical Technology, Inc.
Surgical implant template, reusable| Primary Device ID | 00846468086732 |
| NIH Device Record Key | e6e71454-c449-430b-ad34-10b06fb4b0fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortilink®-L IBF System with TETRAfuse 3D Technology |
| Version Model Number | 65-L-TRL14-8 |
| Catalog Number | 65-L-TRL14-8 |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468086732 [Primary] |
FDA Product Code
| HWT | TEMPLATE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
[00846468086732]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2018-08-24 |
On-Brand Devices [Fortilink®-L IBF System with TETRAfuse 3D Technology]
| 00846468087234 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 60mm (L |
| 00846468087227 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 55mm (L |
| 00846468087210 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 50mm (L |
| 00846468087203 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 45mm (L |
| 00846468087197 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 55mm (L |
| 00846468087180 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 50mm (L |
| 00846468087173 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 45mm (L |
| 00846468087166 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 50mm (L |
| 00846468087159 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 45mm (L |
| 00846468087142 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 40mm (L |
| 00846468086756 | Fortilink-L IBF System Trial, 22mm (W) x 8mm (H) |
| 00846468086749 | Fortilink-L IBF System Trial, 18mm (W) x 8mm (H) |
| 00846468086732 | Fortilink-L IBF System Trial, 14mm (W) x 8mm (H) |
Trademark Results [Fortilink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTILINK 87101032 5287571 Live/Registered |
Pioneer Surgical Technology, Inc. 2016-07-12 |
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