| Primary Device ID | 00846468099688 |
| NIH Device Record Key | c57afa6a-e139-43dc-9ee8-24596b79e1f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortilink-C IBF System |
| Version Model Number | 65-C-TRL-S-7-10L |
| Catalog Number | 65-C-TRL-S-7-10L |
| 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 |
| 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 | |
| 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 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 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468099688 [Primary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
[00846468099688]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-27 |
| Device Publish Date | 2021-08-19 |
| 00191083006703 | Interbody Fusion Device |
| 00191083006680 | Interbody Fusion Device |
| 00191083006673 | Interbody Fusion Device |
| 00191083006666 | Interbody Fusion Device |
| 00191083006635 | Interbody Fusion Device |
| 00191083006598 | Interbody Fusion Device |
| 00191083006581 | Interbody Fusion Device |
| 00191083006574 | Interbody Fusion Device |
| 00191083006543 | Interbody Fusion Device |
| 00191083006536 | Interbody Fusion Device |
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