| Primary Device ID | 00846468041052 |
| NIH Device Record Key | aedac5bb-4edf-445c-b5a2-0fad190b1d71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 405-697 |
| Catalog Number | 405-697 |
| 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(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 | 00846468041052 [Primary] |
| HWJ | AWL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
[00846468041052]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-06 |
| Device Publish Date | 2018-10-06 |
| 00846468060787 | Bipolar Forceps, Straight, 9.7", 0.4mm |
| 00846468060527 | Bipolar Forceps, Bent, 9.7", Small |
| 00846468060510 | Bipolar Forceps, Straight, 9.7", Small |
| 00846468060466 | Bipolar Forceps, Bent, 9.7", 1.5mm Tip |
| 00846468060435 | Bipolar Forceps, Bent, 9.7", 1.0mm Tip |
| 00846468060404 | Bipolar Forceps, Bent, 9.7", 0.4mm Tip |
| 00846468057572 | AUXILIARY CASE |
| 00846468050542 | Bone Graft Delivery System |
| 00846468049386 | Bipolar Forceps, Straight, 9.7", 1.5mm |
| 00846468049287 | Bipolar Forceps, Straight, 9.7", Large |
| 00846468049270 | Bipolar Forceps, Straight, 9.7", 1.0mm |
| 00846468041052 | AWL |
| 00846468041045 | HEX DRIVER, 3.5mm |