Modulus Expandable

GUDID 00195377061164

MOD-EX XLIF Instrument Tray

Nuvasive, Inc.

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00195377061164
NIH Device Record Key507d4951-fe26-4270-8442-3c94e59afb6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameModulus Expandable
Version Model Number1970047
Company DUNS053950783
Company NameNuvasive, Inc.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100195377061164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

[00195377061164]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-18
Device Publish Date2023-08-10

On-Brand Devices [Modulus Expandable]

00195377066756MOD-EX PL Instrument Case
00195377061744MOD-EX XLIF, 12x22x60mm 10-25° HL
00195377061737MOD-EX XLIF, 12x22x45mm 10-25° HL
00195377061164MOD-EX XLIF Instrument Tray
00195377056238MOD-EX XLIF, 8x18x60mm 0-15°
00195377056221MOD-EX XLIF, 8x18x55mm 0-15°
00195377056214MOD-EX XLIF, 8x18x50mm 0-15°
00195377056207MOD-EX XLIF, 8x18x45mm 0-15°
00195377056191MOD-EX XLIF, 8x22x60mm 0-15°
00195377056184MOD-EX XLIF, 8x22x55mm 0-15°
00195377056177MOD-EX XLIF, 8x22x50mm 0-15°
00195377056160MOD-EX XLIF, 8x22x45mm 0-15°
00195377056153MOD-EX XLIF, 12x22x55mm 10-25° HL
00195377056146MOD-EX XLIF, 12x22x50mm 10-25° HL
00195377056139MOD-EX XLIF, 10x18x60mm 10-25° HL
00195377056122MOD-EX XLIF, 10x18x55mm 10-25° HL
00195377056115MOD-EX XLIF, 10x18x50mm 10-25° HL
00195377056108MOD-EX XLIF, 10x18x45mm 10-25° HL
00195377056078MOD-EX PL Trial, 11x11mm
00195377056061MOD-EX PL Trial, 11x9mm
00195377056054MOD-EX PL Trial, 9x11mm
00195377056047MOD-EX PL Trial, 9x9mm
00195377056030MOD-EX PL Funnel Stand, Graft Delivery
00195377056023MOD-EX PL Alignment Tool
00195377056016MOD-EX PL Drill
00195377056009MOD-EX PL Removal Tool
00195377055996MOD-EX PL Funnel, Graft Delivery
00195377055989MOD-EX PL Tamp
00195377055965MOD-EX PL Handle, Torque Limiting
00195377055958MOD-EX PL Counter Torque
00195377055941MOD-EX PL Adjustment Tool, Strike Plate
00195377055910MOD-EX PL Trial, 7x11mm
00195377055903MOD-EX PL Trial, 7x9mm
00195377055590MOD-EX XLIF, 10x22x60mm 10-25° HL
00195377055583MOD-EX XLIF, 10x22x55mm 10-25° HL
00195377055576MOD-EX XLIF, 10x22x50mm 10-25° HL
00195377055569MOD-EX XLIF, 10x22x45mm 10-25° HL
00195377045409MOD-EX PL Strike Plate
00195377043535MOD-EX XLIF Inserter, Low Profile
00195377043511MOD-EX XLIF Inserter, All In One
00195377042194MOD-EX XLIF Torque Handle, Differential
00195377042187MOD-EX XLIF Torque Handle
00195377042170MOD-EX XLIF Handle, Counter Torque
00195377042163MOD-EX XLIF Differential Expander
00195377042156MOD-EX XLIF Expansion Adapter
00195377042149MOD-EX XLIF Adapter, Slap Hammer
00195377042132MOD-EX XLIF Expansion Driver
00195377056351MOD-EX PL, 7x9x32mm 17°
00195377056443MOD-EX PL, 9x9x36mm 16°
00195377056436MOD-EX PL, 9x9x32mm 22° HL
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