360 ENDOSCOPIC APPLICATOR

GUDID 00815634020672

360° ENDOSCOPIC APPLICATOR WITH TETHER, 5MM x 40CM, 1:1 RATIO (US Indication)

MICROMEDICS, INC.

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 00815634020672
• NIH Device Record Key: 02295eb5-e86f-46b9-b4d4-c21c4c340bbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 360 ENDOSCOPIC APPLICATOR
• Version Model Number: SA-3768
• 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	00815634020672 [Primary]
GS1	10815634020679 [Package]; Package: SHELF BOX [5 Units]; In Commercial Distribution
GS1	20815634020676 [Package]; Contains: 10815634020679; Package: SHIP BOX [1 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-25

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