Interspinous Plate System 29-0007

GUDID 00815362022191

Tissue Awl

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00815362022191
• NIH Device Record Key: 7e4e7921-0524-451f-8f76-8450414f3027
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Interspinous Plate System
• Version Model Number: 29-0007
• Catalog Number: 29-0007
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	00815362022191 [Primary]

FDA Product Code

• HWJ: Awl

Sterilization

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

[00815362022191]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-11
• Device Publish Date: 2019-04-03

On-Brand Devices [Interspinous Plate System]

• 00815362022115: 55mm Interspinous Female Plate
• 00815362022108: 50mm Interspinous Female Plate
• 00815362022092: 45mm Interspinous Female Plate
• 00815362022085: 40mm Interspinous Female Plate
• 00815362022078: 35mm Interspinous Female Plate
• 00815362022061: 55mm Interspinous Male Plate
• 00815362022054: 50mm Interspinous Male Plate
• 00815362022047: 45mm Interspinous Male Plate
• 00815362022030: 40mm Interspinous Male Plate
• 00815362022023: 35mm Interspinous Male Plate
• 00815362022603: Self Drilling Ø4.0mm Fixed Screw 12mm
• 00815362022597: Self Drilling Ø4.0mm Fixed Screw 10mm
• 00815362022580: Self Drilling Ø4.5mm Variable Screw 20mm
• 00815362022573: Self Drilling Ø4.5mm Variable Screw 18mm
• 00815362022566: Self Drilling Ø4.5mm Variable Screw 16mm
• 00815362022559: Self Drilling Ø4.5mm Variable Screw 14mm
• 00815362022542: Self Drilling Ø4.5mm Variable Screw 12mm
• 00815362022535: Self Drilling Ø4.5mm Variable Screw 10mm
• 00815362022528: Self Drilling Ø4.0mm Variable Screw 20mm
• 00815362022511: Self Drilling Ø4.0mm Variable Screw 18mm
• 00815362022504: Self Drilling Ø4.0mm Variable Screw 16mm
• 00815362022498: Self Drilling Ø4.0mm Variable Screw 14mm
• 00815362022481: Self Drilling Ø4.0mm Variable Screw 12mm
• 00815362022474: Self Drilling Ø4.0mm Variable Screw 10mm
• 00815362022450: AIO Final Tightener
• 00815362022443: AIO Cap Screw Inserter
• 00815362022436: All In One Inserter
• 00815362022429: 30mm Trial
• 00815362022412: 28mm Trial
• 00815362022405: 30mm Interspinous Female Plate
• 00815362022399: Reli™ SP 30mm Interspinous Male Plate
• 00815362022382: Reli™ SP 28mm Interspinous Female Plate
• 00815362022375: Reli™ SP 28mm Interspinous Male Plate
• 00815362022351: ISP Retractor Sterilization Case
• 00815362022337: ISP Sterilization Case
• 00815362022320: Straight Plate Holder
• 00815362022313: Plate Holder
• 00815362022306: 90mm Caspar Sleeve
• 00815362022290: 75mm Caspar Sleeve
• 00815362022283: Caspar Pin Driver
• 00815362022276: Caspar Retractor
• 00815362022269: 10mm Drill
• 00815362022252: Parallel Compressor
• 00815362022245: 55mm Trial
• 00815362022238: 50mm Trial
• 00815362022221: 45mm Trial
• 00815362022214: 40mm Trial
• 00815362022207: 35mm Trial
• 00815362022191: Tissue Awl
• 00815362022184: Counter Torque