primaLOK-SP

GUDID 00813210022430

Implant Sizer - 15mm

WENZEL SPINE, INC.

Spinal implant trial

• Primary Device ID: 00813210022430
• NIH Device Record Key: 9a550c8b-ff7f-4865-ab27-3d8177f4865a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: primaLOK-SP
• Version Model Number: 800-0315
• Company DUNS: 832543255
• Company Name: WENZEL SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813210022430 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

[00813210022430]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-31
• Device Publish Date: 2019-12-23

On-Brand Devices [primaLOK-SP]

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