| Primary Device ID | 00846468040741 |
| NIH Device Record Key | 371b4d47-746b-4f91-bc86-7d047bbf0d61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STERNAL CABLE SYSTEM |
| Version Model Number | 400-415 |
| Catalog Number | 400-415 |
| 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 | |
| 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 | 00846468040741 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
Moist Heat or Steam Sterilization
[00846468040741]
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 |
| 00846468053727 | SS BLUNT NEEDLE, 64mm, 4 CABLES PER POUCH |
| 00846468042264 | Instrument Case |
| 00846468041182 | Ti Two Pack Sternal Crimps |
| 00846468041175 | Ti BLUNT NEEDLES, 4 CABLES PER POUCH |
| 00846468041168 | Ti Reverse Cutting Needle, 4 Cables Per Pouch |
| 00846468041151 | Ti 3 Blunt & 1 Cutting Edge Needle, 4 Cables Per Pouch |
| 00846468041144 | Ti Tapered Cutting Needle, 4 Cables Per Pouch |
| 00846468041076 | Crimper/Tensioner |
| 00846468041021 | SS Blunt Needle, 4 Cables Per Pouch |
| 00846468041014 | SS 3 Blunt & 1 Cutting Edge Needle, 4 Cables Per Pouch |
| 00846468041007 | SS Blunt Needle, 1 Cable Per Pouch |
| 00846468040956 | Ti Cutting Edge Needle, 4 Cables Per Pouch |
| 00846468040949 | SS 3 Tapered & 1 Reverse Cutting Needle, 4 Cables Per Pouch |
| 00846468040925 | SS Revers Cutting Needle, 3 Cables Per Pouch |
| 00846468040918 | SS Cutting Edge Needle, 1 Cable Per Pouch |
| 00846468040901 | SS Cutting Edge Needle, 3 Cables Per Pouch |
| 00846468040895 | SS Cutting Edge Needle, 4 Cables Per Pouch |
| 00846468040789 | INSTRUMENT CASE |
| 00846468040772 | TENSIONER HANDLE |
| 00846468040765 | SS Tapered Cutting Needle, 1 Cable Per Pouch |
| 00846468040758 | SS Tapered Cutting Needle, 4 Cables Per Pouch |
| 00846468040741 | CRIMPER / TENSIONER |
| 00846468040734 | SS Reverse Cutting Needle, 1 Cable Per Pouch |
| 00846468040727 | SS Reverse Cutting Needle, 4 Cables Per Pouch |
| 00846468040710 | Cable Cutter |
| 00846468040697 | SS Two Pack Sternal Crimps |