MD-Max ULIF 43-6100-080

GUDID 00840019926126

Ipsilateral Sleeve Assembly, 80mm

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019926126
NIH Device Record Key27bbc83a-a316-4248-8371-c67d4e9625ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD-Max ULIF
Version Model Number43-6100-080
Catalog Number43-6100-080
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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
GS100840019926126 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019926126]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-20
Device Publish Date2019-05-10

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008400199260728.5mm MD-Max Triple Lead Tap
008400199260657.5mm MD-Max™ Triple Lead Tap
008400199260586.5mm MD-Max™ Triple Lead Tap
008400199260415.5mm MD-Max™ Triple Lead Tap
00840019926034Medial Blade Bar
00840019926027Medial Blade Rack Assembly
00840019926010Medial Retractor Blade, 110 mm
00840019926003Medial Retractor Blade, 100 mm
00840019925990Medial Retractor Blade, 90 mm
00840019925983Medial Retractor Blade, 80 mm
00840019925976Medial Retractor Blade, 70 mm
00840019925969Medial Retractor Blade, 60 mm
00840019925952Medial Retractor Blade, 50 mm
00840019925945Medial Retractor Blade, 40 mm
00840019925938Hexdriver
00840019925921Drill, Pedicle Targeting
00840019925907Torque Limiting T-Handle 36 in-lbs
00840019925891Reusable Light Cable-Lumitex
00840019926157MD-Max Bottle Cap Reducer
00840019926140Contralateral Sleeve Assembly
00840019926133Ipsilateral Sleeve Assembly, 100mm
00840019926126Ipsilateral Sleeve Assembly, 80mm
00840019926119Ipsilateral Sleeve Assembly, 60mm
00840019926102Ipsilateral Sleeve Assembly, 40mm
00840019926096Bilateral Retractor Assembly
00840019926089Lumitex Light Source
00840019915427Ø8.5 MD-Max™ Triple Lead Screw 60mm
00840019915410Ø8.5 MD-Max™ Triple Lead Screw 55mm
00840019915403Ø8.5 MD-Max™ Triple Lead Screw 50mm
00840019915397Ø8.5 MD-Max™ Triple Lead Screw 45mm
00840019915380Ø8.5 MD-Max™ Triple Lead Screw 40mm
00840019915373Ø8.5 MD-Max™ Triple Lead Screw 35mm
00840019915366Ø8.5 MD-Max™ Triple Lead Screw 30mm
00840019915359Ø8.5 MD-Max™ Triple Lead Screw 25mm
00840019915342Ø8.5 MD-Max™ Triple Lead Screw 100mm
0084001991533543-TL-7560
00840019915328Ø7.5 MD-Max™ Triple Lead Screw 55mm
00840019915311Ø7.5 MD-Max™ Triple Lead Screw 50mm
00840019915304Ø7.5 MD-Max™ Triple Lead Screw 45mm
00840019915298Ø7.5 MD-Max™ Triple Lead Screw 40mm
00840019915281Ø7.5 MD-Max™ Triple Lead Screw 35mm
00840019915274Ø7.5 MD-Max™ Triple Lead Screw 30mm
00840019915267Ø7.5 MD-Max™ Triple Lead Screw 25mm
00840019915250Ø6.5 MD-Max™ Triple Lead Screw 60mm
00840019915243Ø6.5 MD-Max™ Triple Lead Screw 55mm
00840019915236Ø6.5 MD-Max™ Triple Lead Screw 50mm
00840019915212Ø6.5 MD-Max™ Triple Lead Screw 40mm
00840019915205Ø6.5 MD-Max™ Triple Lead Screw 35mm
00840019915199Ø6.5 MD-Max™ Triple Lead Screw 30mm
00840019915182Ø6.5 MD-Max™ Triple Lead Screw 25mm

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