Duplotip

GUDID 20815634020546

Duplotip with Snap Lock, 20G x 26 cm

MICROMEDICS, INC.

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 20815634020546
• NIH Device Record Key: 512a3f6e-fa88-4fb6-b695-eb810b0c9dfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duplotip
• Version Model Number: SA375003005555
• 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	00815634020542 [Primary]
GS1	10815634020549 [Package]; Contains: 00815634020542; Package: Shelf Box [3 Units]; In Commercial Distribution
GS1	20815634020546 [Package]; Contains: 10815634020549; Package: Ship Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033589

FDA Product Code

• FMF: Syringe, Piston

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: 2018-07-16
• Device Publish Date: 2018-06-15

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