UniVise Spinous Process Fixation Plate System 48590101

GUDID 07613327121971

INSERTER INNER SHAFT

Stryker Corporation

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID07613327121971
NIH Device Record Keyc8727613-776f-42db-b8cb-c5e919e45983
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniVise Spinous Process Fixation Plate System
Version Model Number48590101
Catalog Number48590101
Company DUNS149183167
Company NameStryker Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS107613327121971 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


[07613327121971]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-11
Device Publish Date2019-11-22

On-Brand Devices [UniVise Spinous Process Fixation Plate System]

07613327123630TRIAL
07613327121957TRIAL
07613327121971INSERTER INNER SHAFT
07613327121964INSERTER

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