ShurFit ACIF Titanium CRT005

GUDID 00815362022122

ACIF Cage 5 degree x 5mm

PRECISION SPINE, INC.

Metallic spinal fusion cage, non-sterile
Primary Device ID00815362022122
NIH Device Record Key06be1b84-da4a-42b8-9ac0-4a0cd62d5bd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit ACIF Titanium
Version Model NumberCRT005
Catalog NumberCRT005
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100815362022122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDKProsthesis, Hip, Cement Restrictor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815362022122]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-05
Device Publish Date2019-03-28

On-Brand Devices [ShurFit ACIF Titanium ]

00840019929271ACIF Cage 5 degree x 10mm
00840019929264ACIF Cage 5 degree x 9mm
00840019929240ACIF Cage 5 degree x 7mm
00840019929257ACIF Cage 5 degree x 8mm
00840019929233ACIF Cage 5 degree x 6mm
00815362022122ACIF Cage 5 degree x 5mm

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