Biocomposites

GUDID 10815634020891

GRAFT DELIVERY 15 mL, Closed, with O ring cap

MICROMEDICS, INC.

Bone graft delivery kit

• Primary Device ID: 10815634020891
• NIH Device Record Key: f3d55399-3c66-4037-991f-29a9c188e654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biocomposites
• Version Model Number: 990-001
• 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	00815634020894 [Primary]
GS1	10815634020891 [Package]; Contains: 00815634020894; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20815634020898 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151543

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: 2021-05-03
• Device Publish Date: 2021-04-23

Devices Manufactured by MICROMEDICS, INC.

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• 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