DUPLOSPRAY

GUDID 00815634020658

DUPLOSPRAY MIS APPLICATOR, 40CM (Gas Assist 1:1 used with Tisseel)

MICROMEDICS, INC.

Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 00815634020658
• NIH Device Record Key: cddf936d-5c39-48ea-8536-dabdcb38e109
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUPLOSPRAY
• Version Model Number: 0600030
• 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	00815634020658 [Primary]
GS1	10815634020655 [Package]; Package: SHELF BOX [5 Units]; In Commercial Distribution
GS1	20815634020652 [Package]; Contains: 10815634020655; Package: SHIP BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061092

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 [DUPLOSPRAY]

• 00815634020665: DUPLOSPRAY MIS APPLICATOR, 20CM (Gas Assist 1:1 used with Tisseel)
• 00815634020658: DUPLOSPRAY MIS APPLICATOR, 40CM (Gas Assist 1:1 used with Tisseel)
• 00815634020641: DUPLOSPRAY MIS APPLICATOR, 30CM (Gas Assist 1:1 used with Tisseel)
• 20815634020584: DuploSpray MIS Applicator with Snap Lock, 30cm
• 20815634020577: DuploSpray MIS Applicator with Snap Lock, 20cm
• 20815634020492: DUPLOSPRAY MIS APPLICATOR, 20CM (Gas Assist 1:1 used with Tisseel)
• 20815634020485: DUPLOSPRAY MIS APPLICATOR, 40CM (Gas Assist 1:1 used with Tisseel)
• 20815634020478: DUPLOSPRAY MIS APPLICATOR, 30CM (Gas Assist 1:1 used with Tisseel)
• 00815634020214: DUPLOSPRAY REPLACEMENT TIPS (Tip Alignment Tool with 2 Spray Tips per pouch)
• 00815634020856: DUPLOSPRAY MIS REGULATOR 1.5 BAR B11
• 10815634020594: DuploSpray MIS Applicator with Snap Lock 40cm