ShurFit MALIF System 23-ES1850-14

GUDID 00840019925433

MALIF Sizer 18x50x14mm

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019925433
NIH Device Record Keyb2bce702-5818-4e1f-a856-e277a691ec6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit MALIF System
Version Model Number23-ES1850-14
Catalog Number23-ES1850-14
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
GS100840019925433 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019925433]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-04
Device Publish Date2019-03-27

On-Brand Devices [ShurFit MALIF System]

00840019925501ShurFit™ MALIF Implant Case (Empty)
00840019925495ShurFit™ MALIF Instrument Case # 2 (Empty)
00840019925488ShurFit™ MALIF Instrument Case # 1 (Empty)
00840019925471MALIF Sizer 22x50x14mm
00840019925464MALIF Sizer 22x50x12mm
00840019925457MALIF Sizer 22x50x10mm
00840019925440MALIF Sizer 22x50x08mm
00840019925433MALIF Sizer 18x50x14mm
00840019925426MALIF Sizer 18x50x12mm
00840019925402MALIF Sizer 18x50x08mm
00840019925396Angled Cobb 22mm
00840019925365Straight Cobb 18mm
00840019925358Large Chisel 12mm Width
00840019925341Small Chisel 6mm Width
00840019925334Paddle Shaver 50mm Length x 14mm Height
00840019925303Paddle Shaver 50mm Length x 08mm Height
00840019925297Paddle Shaver 50mm Length x 06mm Height
00840019925273Cup Curette 6mm x 90˚ Up Pulling
00840019925266Cup Curette 6mm x 45˚Up Pulling
00840019925235Cup Curette 4mm x 45˚ Up Pulling
00840019925211Disc Spreader
00840019925181Implant Slides
00840019925174Implant Extractor
00840019925150Box Curette 8mm
00840019925136Ring Curette 8mm Large
00840019925129Ring Curette 6mm Small
00840019925112Rasp
00840019916387Rongeurs Pituitary Straight Kerrison 6mm x 330mm
00840019916370Rongeurs Pituitary Straight Kerrison 4mm x 330mm
00840019916363Punch Kerrison Lamina 40˚ Up Bite 6mm x 330mm
00840019916356Punch Kerrison Lamina 40˚ Up Bite 4mm x 330mm
00840019925419MALIF Sizer 18x50x10mm
00840019925327Paddle Shaver 50mm Length x 12mm Height
00840019925310Paddle Shaver 50mm Length x 10mm Height
00840019925280T Handle Quick Connect
00840019925259Cup Curette 6mm Straight Up Cup
00840019925242Cup Curette 4mm 90˚ Up Pulling
00840019925228Cup Curette 4mm Straight Up Cup
00840019925204LLIF Slap Hammer
00840019925198LLIF Tamp
00840019925167LLIF Inserter Tool
00840019925143Box Curette 6mm

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