Gasless Tip

GUDID 10815634021010

Baxter - Gasless Applicator 25CM

MICROMEDICS, INC.

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 10815634021010
• NIH Device Record Key: e3b9d154-446a-4cbb-bb49-5d80227fd7a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gasless Tip
• Version Model Number: 601153
• 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	00815634021013 [Primary]
GS1	10815634021010 [Package]; Contains: 00815634021013; Package: Shelf Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042834

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [Gasless Tip]

• 10815634021027: Baxter - Gasless Applicator 40CM
• 10815634021010: Baxter - Gasless Applicator 25CM
• 10815634021003: Baxter - Gasless Applicator Open