Baxter

GUDID 10815634020600

Spray Set 360 Endoscopic Applicator with Snap Lock

MICROMEDICS, INC.

Fibrin sealant biochemical preparation/application kit, endoscopic

• Primary Device ID: 10815634020600
• NIH Device Record Key: 74f64e78-eb20-40a1-af40-375ce83f987c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baxter
• Version Model Number: SA3768111
• 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	00815634020603 [Primary]
GS1	10815634020600 [Package]; Contains: 00815634020603; Package: Inner Pack [5 Units]; In Commercial Distribution
GS1	20815634020607 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122526

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: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [Baxter ]

• 10815634020600: Spray Set 360 Endoscopic Applicator with Snap Lock
• 10815634020860: 360 DEGREE ENDOSCOPIC APPLICATOR WITH TETHER, 5MM X 40CM, 1:1 RATIO
• 10815634020815: DuploSpray MIS Applicator, 30cm, Coseal
• 10815634020792: DuploSpray MIS Applicator, Coseal 20cm
• 10815634020761: RIGID DUPLOTIP WITH SNAPLOCK 5 mm x 40 cm (3pk)
• 10815634020617: Spray Set 360 Endoscopic Applicator with snap lock