OSTEOPRECISION

GUDID 00815634020436

OsteoPrecision Vented System, Hydration Tube, 5cm Cannula

MICROMEDICS, INC.

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• Primary Device ID: 00815634020436
• NIH Device Record Key: fb8626e8-9f2c-4aae-8191-51b3aaf0f07e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEOPRECISION
• Version Model Number: GD-1215-050
• Company DUNS: 066839630
• Company Name: MICROMEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815634020436 [Primary]
GS1	10815634020433 [Package]; Package: SHELF BOX [5 Units]; In Commercial Distribution
GS1	20815634020430 [Package]; Contains: 10815634020433; Package: SHIP BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151543

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-25

On-Brand Devices [OSTEOPRECISION]

• 20815634020454: OSTEOPRECISION VENTED SYSTEM, HYDRATION TUBE, 15cm CANNULA
• 00815634020443: OsteoPrecision Vented System, Hydration Tube, 10cm Cannula
• 00815634020436: OsteoPrecision Vented System, Hydration Tube, 5cm Cannula
• 00815634020429: OsteoPrecision Vented System, Hydration Adapter, 15cm Cannula
• 00815634020412: OsteoPrecision Vented System, Hydration Adapter, 10cm Cannula
• 00815634020405: OsteoPrecision Vented System, Hydration Adapter, 5cm Cannula
• 00815634020399: OsteoPrecision Non-Vented/Closed System 15cm Cannula
• 00815634020382: OsteoPrecision Non-Vented/Closed System 10cm Cannula
• 00815634020375: OsteoPrecision Non-Vented/Closed System 5cm Cannula
• 00815634010450: GD-1215-150
• 10815634021331: Curved Cannula Graft Delivery, Int. Stylet, Closed, 15mL(15cm)
• 10815634021324: Curved Cannula Graft Delivery, Int. Stylet, Closed, 15mL(10cm)
• 10815634021300: BioXpress Curved Graft Delivery, 10cm
• 10815634021294: BioXpress Curved Graft Delivery, 15cm