GUDID 00815634020313

2-Part Endoscopic Applicator with Malleable Tip

MICROMEDICS, INC.

Fibrin sealant biochemical preparation/application kit, endoscopic

• Primary Device ID: 00815634020313
• NIH Device Record Key: 2f75452c-4ba2-4445-947a-9390354b6ee0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 0600127
• 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: true
• 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	00815634020313 [Primary]
GS1	10815634020310 [Package]; Package: SHELFL BOX [6 Units]; In Commercial Distribution
GS1	20815634020317 [Package]; Contains: 10815634020310; Package: SHIP BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123847

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

Devices Manufactured by MICROMEDICS, INC.

• 10815634021768 - Fibrijet: 2024-06-26 Endoscopic Catheter Introducer
• 00815634020788 - Biomet Biologics: 2023-12-13 Biomet Biologics Regulator
• 10815634021089 - Nordson Medical: 2023-06-14 MALLEABLE APPLICATOR TIP, STERILE, 0.160in OD x 5.51in L
• 00815634021358 - Pramand: 2023-05-19 Air Assisted Sprayer
• 10815634021782 - FibriJet: 2023-03-29 FIBRIJET REGULATOR
• 30815634021472 - FibriJet: 2023-03-08 Case 250 (bulk) individually pouched AMS600 devices corresponding to pouch UDI-DI 00815634021471
• 30815634021519 - FibriJet: 2023-03-08 MAGELLAN SPRAY TIP, DUAL SPRAY, BULK STERILE, Case of 250, corresponding to individual pouched AMS700 UDI-DI of 00815634021518
• 10815634021065 - Nordson Medical: 2022-11-14 Gasless Applicator 40CM, OUS - Baxter