primaLOK-SP

GUDID 00813210022454

Flat Rasp

WENZEL SPINE, INC.

Bone file/rasp, manual
Primary Device ID00813210022454
NIH Device Record Key3f1cd509-5bbe-410d-a4f5-e8f2215098e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameprimaLOK-SP
Version Model Number800-0402
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
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
GS100813210022454 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

[00813210022454]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-31
Device Publish Date2019-12-23

On-Brand Devices [primaLOK-SP]

00813210022454Flat Rasp
00813210022447Implant Sizer - 18mm
00813210022430Implant Sizer - 15mm
00813210022423Implant Sizer - 12mm
00813210022416Implant Sizer - 10mm
00813210022409Implant Sizer - 8mm
00813210022386Implant Sizer - 4mm
00813210022379Backup Plate Caddy
00813210022362Laminar Spread
00813210022355Retractor Extension
00813210022348Implant Sizer Handle
00813210022331Distractor Screw Driver Ha
00813210022317Retractor Frame (Locking Ring Compressor)
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