ShurFit MALIF Interbody System 23-9047

GUDID 00840019925372

Straight Cobb 22mm

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019925372
NIH Device Record Key537ce6f6-edea-4c0f-85a7-4bd2d5f35d9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit MALIF Interbody System
Version Model Number23-9047
Catalog Number23-9047
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
GS100840019925372 [Primary]

FDA Product Code

HTEElevator

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019925372]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-09
Device Publish Date2019-08-30

On-Brand Devices [ShurFit MALIF Interbody System]

00840019936903ShurFit™ MALIF Implant Case
00840019936897ShurFit™ MALIF Instrument Case # 2
00840019936880ShurFit™ MALIF Instrument Case # 1
00840019925389Angled Cobb 18mm
00840019925372Straight Cobb 22mm

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