Anterior Cervical Interbody Fusion Device HTR-45-1205

GUDID 00840019921817

ACIF Rasp, Wide, 2mm Stop (5mm Height)

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019921817
NIH Device Record Keyfbfde127-04de-4924-a39b-c46571c41fcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnterior Cervical Interbody Fusion Device
Version Model NumberHTR-45-1205
Catalog NumberHTR-45-1205
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
GS100840019921817 [Primary]

FDA Product Code

HTRRasp

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019921817]

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 [ Anterior Cervical Interbody Fusion Device]

00840019921909Shurfit ACIF Case
00840019921879ACIF Rasp, Wide, 2mm Stop (11mm Height)
00840019921862ACIF Rasp, Wide, 2mm Stop (10mm Height)
00840019921855ACIF Rasp, Wide, 2mm Stop (9mm Height)
00840019921831ACIF Rasp, Wide, 2mm Stop (7mm Height)
00840019921824ACIF Rasp, Wide, 2mm Stop (6mm Height)
00840019921794ACIF Rasp, Wide, w/o Stop (11mm Height)
00840019921770ACIF Rasp, Wide, w/o Stop (9mm Height)
00840019921763ACIF Rasp, Wide, w/o Stop (8mm Height)
00840019921756ACIF Rasp, Wide, w/o Stop (7mm Height)
00840019921749ACIF Rasp, Wide, w/o Stop (6mm Height)
00840019921725ACIF Rasp, Narrow, 2mm Stop (12mm Height)
00840019921718ACIF Rasp, Narrow, 2mm Stop (11mm Height)
00840019921701ACIF Rasp, Narrow, 2mm Stop (10mm Height)
00840019921695ACIF Rasp, Narrow, 2mm Stop (9mm Height)
00840019921688ACIF Rasp, Narrow, 2mm Stop (8mm Height)
00840019921671ACIF Rasp, Narrow, 2mm Stop (7mm Height)
00840019921664ACIF Rasp, Narrow, 2mm Stop (6mm Height)
00840019921657ACIF Rasp, Narrow, 2mm Stop (5mm Height)
00840019921640ACIF Rasp, Narrow, w/o Stop (12mm Height)
00840019921633ACIF Rasp, Narrow, w/o Stop (11mm Height)
00840019921626ACIF Rasp, Narrow, w/o Stop (10mm Height)
00840019921619ACIF Rasp, Narrow, w/o Stop (9mm Height)
00840019921602ACIF Rasp, Narrow, w/o Stop (8mm Height)
00840019921596ACIF Rasp, Narrow, w/o Stop (7mm Height)
00840019921589ACIF Rasp, Narrow, w/o Stop (6mm Height)
00840019921572ACIF Rasp, Narrow, w/o Stop (5mm Height)
00840019921565Cervical Sizer 12mm
00840019921558Cervical Sizer 11mm
00840019921541Cervical Sizer 10mm
00840019921534Cervical Sizer 9mm
00840019921527Cervical Sizer 8mm
00840019921510Cervical Sizer 7mm
00840019921503Cervical Sizer 6mm
00840019921497Cervical Sizer 5mm
00840019916349ACIF Tamp
00815362022467ACIF Inserter
00840019921893ACIF System Tray
00840019921886ACIF Rasp, Wide, 2mm Stop (12mm Height)
00840019921848ACIF Rasp, Wide, 2mm Stop (8mm Height)
00840019921817ACIF Rasp, Wide, 2mm Stop (5mm Height)
00840019921800ACIF Rasp, Wide, w/o Stop (12mm Height)
00840019921787ACIF Rasp, Wide, w/o Stop (10mm Height)
00840019921732ACIF Rasp, Wide, w/o Stop (5mm Height)

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