CoLink® PCR Plating System

GUDID 00810021864495

CoLink® PCR Universal Plate, 4-hole

IN2BONES USA, LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00810021864495
• NIH Device Record Key: c593e7cf-8133-4a19-9444-076397b1baec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink® PCR Plating System
• Version Model Number: P40 SP014
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00810021864495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213698

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-06
• Device Publish Date: 2022-06-28

On-Brand Devices [CoLink® PCR Plating System]

• 00810021864556: CoLink® PCR MTP Plate NX, Narrow, 0° DF, 6-Hole, Left
• 00810021864549: CoLink® PCR MTP Plate NX, Narrow, 0° DF, 6-Hole, Right
• 00810021864532: CoLink® PCR MTP Plate NX Narrow, 4° DF, 6-Hole, Left
• 00810021864525: CoLink® PCR MTP Plate NX Narrow, 4° DF, 6-Hole, Right
• 00810021864518: CoLink® PCR Universal Plate, 6-hole
• 00810021864501: CoLink® PCR Universal Plate, 5-hole
• 00810021864495: CoLink® PCR Universal Plate, 4-hole
• 00810021864488: CoLink® PCR Universal Plate, 3-hole
• 00810021864471: CoLink® PCR Universal Plate, 2-hole