Nordson Medical

GUDID 10815634020990

NuVasive Graft Delivery Syringe

MICROMEDICS, INC.

Bone graft delivery kit

• Primary Device ID: 10815634020990
• NIH Device Record Key: 93929f87-c931-4931-ba4c-913146cdf329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nordson Medical
• Version Model Number: 5125000
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815634020993 [Primary]
GS1	10815634020990 [Package]; Contains: 00815634020993; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20815634020997 [Package]; Package: Case [10 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-03
• Device Publish Date: 2021-04-23

On-Brand Devices [Nordson Medical]

• 10815634020884: DUAL SPRAY PROCEDURE KIT
• 10815634021126: RATIO PROCEDURE KIT 11:1 RATIO
• 10815634021188: Endoscopic Applicator with Mixing Tip, 5mm x 40cm, 1:1 Ratio
• 10815634020952: Custom OsteoPrecision Accessory kit
• 10815634021263: DuploTip with Snap Lock, 5mm x 32cm
• 10815634021218: Spray Applicator Kit
• 10815634020990: NuVasive Graft Delivery Syringe
• 10815634020914: Applicator Assembly procedure kit with spray tips
• 10815634021119: Viscous-Spray II, 11:1 Ratio Applicator Assembly with Dual Spray Tip
• 00815634021105: Viscous-Spray Low Viscosity Ratio Applicator with 3cm Mixing/Spray Tip
• 00815634021099: Viscogel High Viscosity Ratio Applicator with 10cm Mixing Tip
• 10815634021072: Applicator Tip, Dual Cannula, 20 ga x 4'' (10.2cm)
• 10815634020976: Applicator Tip, Dual Cannula, 20 ga x 2' (5.1 cm)
• 10815634020778: Applicator Tip Dual Spray
• 10815634020969: Applicator Assembly 10cc Syringe 1:1 Ratio
• 10815634020921: Aerosol Applicator Kit W/Tips, 11:1 Ratio
• 10815634020877: RATIO PROCEDURE KIT 11:1 RATIO
• 00815634021129: Applicator Tip, Single Spray
• 10815634021041: Gasless Applicator 25CM, OUS - Baxter
• 10815634021034: Gasless Applicator Open, OUS - Baxter
• 10815634021201: Baxter Replacement Tips
• 10815634021065: Gasless Applicator 40CM, OUS - Baxter
• 10815634021089: MALLEABLE APPLICATOR TIP, STERILE, 0.160in OD x 5.51in L