| Primary Device ID | 00846468025885 |
| NIH Device Record Key | aa2baa37-3494-4d3a-8653-cc953b5d2448 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SLIMFUSE ANTERIOR CERVICAL PLATE SYSTEM |
| Version Model Number | 21-MODTAP-12 |
| Catalog Number | 21-MODTAP-12 |
| 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(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468003555 [Primary] |
| GS1 | 00846468025885 [Primary] |
| HWX | TAP, BONE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
[00846468025885]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-30 |
| Device Publish Date | 2019-12-21 |
| 00846468062682 | Final Driver, Extended |
| 00846468062675 | Screw Inserter, Cannulated |
| 00846468050580 | Disposable Torque-Limiting Final Driver |
| 00846468049317 | HOLDING PIN INSERTER, MODULAR |
| 00846468025960 | DRIVER, TORQUE LIMITING |
| 00846468025946 | STANDARD PLATE CADDY |
| 00846468025939 | SCREW PLATE CADDY |
| 00846468025922 | PLATE HOLDER |
| 00846468025915 | PLATE BENDER |
| 00846468025908 | TEMPORARY HOLDING PIN INSERTER/EXTRACTOR |
| 00846468025892 | TEMPORARY HOLDING PIN |
| 00846468025885 | MODULAR TAP |
| 00846468025878 | MODULAR DRILL |
| 00846468025861 | MODULAR DRILL |
| 00846468025854 | MODULAR BONE AWL |
| 00846468025847 | MODULAR BONE AWL |
| 00846468025830 | GUIDE |
| 00846468025823 | INSTRUMENT CASE |
| 00846468025816 | INSTRUMENT, GUIDE SLEEVE |
| 00846468025809 | INSTRUMENT, HANDLED GUIDE |
| 00846468025793 | SCREW DRIVER, INTERNAL SET SCREW |
| 00846468025786 | SCREW DRIVER, INTERNAL SET SCREW |
| 00846468025779 | FIXED HANDLED TAP |
| 00846468025762 | FIXED HANDLED TAP |
| 00846468025755 | FIXED HANDLED DRILL |
| 00846468025748 | FIXED HANDLED DRILL |
| 00846468025731 | FIXED HANDLED BONE AWL |
| 00846468025724 | FIXED HANDLED BONE AWL |
| 00846468025717 | DYNAMIC PLATE CADDY |
| 00846468025700 | SCREW DRIVER, BONE SCREW |
| 00846468025694 | SCREW DRIVER, BONE SCREW |
| 00846468025687 | COUNTER TORQUE INSTRUMENT |
| 00846468025670 | CALIPER |
| 00846468025632 | DYNAMIC PLATE CADDY |
| 00846468025304 | DYNAMIC PLATE CADDY |
| 00846468092603 | SELF-DRILLING SCREW |
| 00846468092443 | FOUR LEVEL, DYNAMIC PLATE |
| 00846468092436 | FOUR LEVEL, DYNAMIC PLATE |
| 00846468092429 | FOUR LEVEL, DYNAMIC PLATE |
| 00846468092412 | FOUR LEVEL, DYNAMIC PLATE |
| 00846468092405 | FOUR LEVEL, DYNAMIC PLATE |
| 00846468092399 | FOUR LEVEL, DYNAMIC PLATE |
| 00846468092382 | THREE LEVEL, DYNAMIC PLATE |
| 00846468092375 | THREE LEVEL, DYNAMIC PLATE |
| 00846468092368 | THREE LEVEL, DYNAMIC PLATE |
| 00846468092351 | THREE LEVEL, DYNAMIC PLATE |
| 00846468092344 | THREE LEVEL, DYNAMIC PLATE |
| 00846468092337 | THREE LEVEL, DYNAMIC PLATE |
| 00846468092320 | THREE LEVEL, DYNAMIC PLATE |