STERNAL CABLE SYSTEM 400-447

GUDID 00846468040772

TENSIONER HANDLE

Pioneer Surgical Technology, Inc.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00846468040772
NIH Device Record Key0f6f6666-aa89-4f70-aba1-9131938af241
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERNAL CABLE SYSTEM
Version Model Number400-447
Catalog Number400-447
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468040772 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


[00846468040772]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-06
Device Publish Date2018-10-06

On-Brand Devices [STERNAL CABLE SYSTEM]

00846468053727SS BLUNT NEEDLE, 64mm, 4 CABLES PER POUCH
00846468042264Instrument Case
00846468041182Ti Two Pack Sternal Crimps
00846468041175Ti BLUNT NEEDLES, 4 CABLES PER POUCH
00846468041168Ti Reverse Cutting Needle, 4 Cables Per Pouch
00846468041151Ti 3 Blunt & 1 Cutting Edge Needle, 4 Cables Per Pouch
00846468041144Ti Tapered Cutting Needle, 4 Cables Per Pouch
00846468041076Crimper/Tensioner
00846468041021SS Blunt Needle, 4 Cables Per Pouch
00846468041014SS 3 Blunt & 1 Cutting Edge Needle, 4 Cables Per Pouch
00846468041007SS Blunt Needle, 1 Cable Per Pouch
00846468040956Ti Cutting Edge Needle, 4 Cables Per Pouch
00846468040949SS 3 Tapered & 1 Reverse Cutting Needle, 4 Cables Per Pouch
00846468040925SS Revers Cutting Needle, 3 Cables Per Pouch
00846468040918SS Cutting Edge Needle, 1 Cable Per Pouch
00846468040901SS Cutting Edge Needle, 3 Cables Per Pouch
00846468040895SS Cutting Edge Needle, 4 Cables Per Pouch
00846468040789INSTRUMENT CASE
00846468040772TENSIONER HANDLE
00846468040765SS Tapered Cutting Needle, 1 Cable Per Pouch
00846468040758SS Tapered Cutting Needle, 4 Cables Per Pouch
00846468040741CRIMPER / TENSIONER
00846468040734SS Reverse Cutting Needle, 1 Cable Per Pouch
00846468040727SS Reverse Cutting Needle, 4 Cables Per Pouch
00846468040710Cable Cutter
00846468040697SS Two Pack Sternal Crimps

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.