UniVise 48590040

GUDID 07613327065657

SPINOUS PROCESS FIXATION PLATE

Stryker Corporation

Lumbar interspinous decompression spacer, sterile
Primary Device ID07613327065657
NIH Device Record Keybcd15481-9037-41d3-9abd-3445fbf75ea8
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniVise
Version Model Number48590040
Catalog Number48590040
Company DUNS149183167
Company NameStryker Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327065657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [UniVise]

07613327281163Specialty Spinous Process Distractor
07613327065657SPINOUS PROCESS FIXATION PLATE
07613327065640SPINOUS PROCESS FIXATION PLATE

Trademark Results [UniVise]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNIVISE
UNIVISE
85714996 4491949 Live/Registered
HOWMEDICA OSTEONICS CORP.
2012-08-28
UNIVISE
UNIVISE
71460444 0403815 Dead/Cancelled
Delta Manufacturing Company; The
1943-05-06

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