primaLOK FF

GUDID 00813210022089

Standard Cannula

WENZEL SPINE, INC.

Endoscopic-access dilator, reusable
Primary Device ID00813210022089
NIH Device Record Key53ca3ee4-cd54-4d23-abe9-ce7abf92b6a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameprimaLOK FF
Version Model Number800-1205
Company DUNS832543255
Company NameWENZEL SPINE, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813210022089 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

[00813210022089]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-27
Device Publish Date2019-12-19

On-Brand Devices [primaLOK FF]

00813210022034Threaded Implant Holder Shaft - Solid
00813210022027Threaded Implant Holder Shaft - Cannulated
00813210022010Implant Driver
00813210022003Removal Driver
00813210021990primaLOK FF 45mm Implant Assembly, Sterile
00813210021983primaLOK FF 40mm Implant Assembly, Sterile
00813210021976primaLOK FF 35mm Implant Assembly, Sterile
00813210021969primaLOK FF 30mm Implant Assembly, Sterile
00813210021952primaLOK FF 25mm Implant Assembly, Sterile
008132100221573mm Cannulated Power Drill
00813210022133Ratcheting Driver Handle
00813210022126Cannula Inserter
00813210022119Single Bevel Access Needle (sterile, single use)
00813210022102Access Needle (sterile, single use)
00813210022096EMG Cannula
00813210022089Standard Cannula
00813210022072Guide Wire Stiffener
00813210022065Cannulated Tap
00813210022041Guide Wire (single use, disposable)
00813210021945Percutaneous Instrument Case
00813210021938Instrument Case
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