ShurFit PLIF Titanium PLIF22-16

GUDID 00840019929363

PLIF Cage 16mm x 22mm

PRECISION SPINE, INC.

Metallic spinal fusion cage, non-sterile
Primary Device ID00840019929363
NIH Device Record Keyfdde300b-2c42-4e75-9a0f-ed987bfe3f29
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit PLIF Titanium
Version Model NumberPLIF22-16
Catalog NumberPLIF22-16
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
GS100840019929363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

Moist Heat or Steam Sterilization


[00840019929363]

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 PLIF Titanium ]

00840019929455PLIF Cage, 16mm x 25mm
00840019929431PLIF Cage, 14mm x 25mm
00840019929424PLIF Cage, 13mm x 25mm
00840019929417PLIF Cage, 12mm x 25mm
00840019929400PLIF Cage, 11mm x 25mm
00840019929394PLIF25-10
00840019929387PLIF Cage 9mm x 25mm
00840019929370PLIF Cage, 8mm x 25mm
00840019929363PLIF Cage 16mm x 22mm
00840019929356PLIF Cage 15mm x 22mm
00840019929349PLIF Cage 14mm x 22mm
00840019929332PLIF Cage 13mm x 22mm
00840019929325PLIF Cage 12mm x 22mm
00840019929318PLIF Cage 11mm x 22mm
00840019929301PLIF Cage 10mm x 22mm
00840019929288PLIF Cage 8mm x 22mm
00840019929448PLIF Cage, 15mm x 25mm
00840019929295PLIF Cage 9mm x 22mm

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