DUPLOTIP

GUDID 00815634020306

2-Part Endoscopic Applicator with Standard Tip

MICROMEDICS, INC.

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• Primary Device ID: 00815634020306
• NIH Device Record Key: c1fd89ba-0c42-4add-a8c4-6d1306f9d3c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUPLOTIP
• Version Model Number: 0600125
• 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	00815634020306 [Primary]
GS1	10815634020303 [Package]; Package: SHELF BOX [6 Units]; In Commercial Distribution
GS1	20815634020300 [Package]; Contains: 10815634020303; Package: SHIP BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120608

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

On-Brand Devices [DUPLOTIP]

• 20815634020560: Duplotip with Snap Lock 5mm x 32cm
• 20815634020553: Duplotip with Snap Lock 5mm x 32cm
• 20815634020546: Duplotip with Snap Lock, 20G x 26 cm
• 20815634020539: Duplotip with Snap Lock 20G x 26cm
• 20815634020522: Duplotip with Snap Lock, 20 GA x 10cm
• 20815634020515: Duplotip with Snap Lock, 20G x 10cm
• 00815634020306: 2-Part Endoscopic Applicator with Standard Tip
• 00815634020146: APPLICATOR TIP DUAL CANNULA 5 MM X 31.8 CM (12.5 IN)
• 00815634020139: APPLICATOR TIP DUAL CANNULA 20 GA X 26.4 CM (10.5 IN)
• 00815634020122: APPLICATOR TIP DUAL CANNULA 20 GA X 10.4 CM
• 00815634020115: DUPLOTIP DUAL CANNULA 5 MM X 32 CM
• 10815634020105: DUPLOTIP DUAL CANNULA 20 GA X 26 CM
• 00815634020092: DUPLOTIP DUAL CANNULA 20 GA X 10 CM