| Primary Device ID | 00846468080235 |
| NIH Device Record Key | 05401fd7-cfc4-4ef4-973e-92217f0d8085 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortilink-C |
| Version Model Number | 65-C-Tamp-SM |
| Catalog Number | 65-C-Tamp-SM |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468080235 [Primary] |
| HXG | TAMP |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
[00846468080235]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-05-26 |
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| 00846468080440 | FORTILINK-C Tetrafuse 14.5x17 9mm, 6L |
| 00846468080433 | FORTILINK-C Tetrafuse 14.5x17 8mm, 6L |
| 00846468080426 | FORTILINK-C Tetrafuse 14.5x17 7mm, 6L |
| 00846468080419 | FORTILINK-C Tetrafuse 14.5x17 6mm, 6L |
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| 00846468080396 | FORTILINK-C Tetrafuse 12x14 11mm, 6L |
| 00846468080389 | FORTILINK-C Tetrafuse 12x14 10mm, 6L |
| 00846468080372 | FORTILINK-C Tetrafuse 12x14 9mm, 6L |
| 00846468080365 | FORTILINK-C Tetrafuse 12x14 8mm, 6L |
| 00846468080358 | FORTILINK-C Tetrafuse 12x14 7mm, 6L |
| 00846468080341 | FORTILINK-C Tetrafuse 12x14 6mm, 6L |
| 00846468080334 | FORTILINK-C Tetrafuse 12x14 5mm, 6L |
| 00846468080327 | FORTILINK-C Tetrafuse 10x12 11mm, 6L |
| 00846468080310 | FORTILINK-C Tetrafuse 10x12 10mm, 6L |
| 00846468080303 | FORTILINK-C Tetrafuse 10x12 9mm, 6L |
| 00846468080297 | FORTILINK-C Tetrafuse 10x12 8mm, 6L |
| 00846468080280 | FORTILINK-C Tetrafuse 10x12 7mm, 6L |
| 00846468080273 | FORTILINK-C Tetrafuse 10x12 6mm, 6L |
| 00846468080266 | Fortilink-C Slaphammer |
| 00846468080259 | Fortilink-C Inserter Housing w/Slaphammer |
| 00846468080242 | Fortilink-C Tamp, Large |
| 00846468080235 | Fortilink-C Tamp, Small |
| 00846468080228 | Fortilink-C Inserter Housing |
| 00846468080211 | Fortilink-C Case |
| 00846468080204 | FORTILINK-C Tetrafuse 10x12 5mm, 6L |
| 00846468080198 | Fortilink-C Inserter Fork Large |
| 00846468080181 | Fortilink-C Inserter Fork Small |