ACTAMAX

GUDID 20815634020843

SURGICAL SPRAY APPLICATOR, 40 CM

MICROMEDICS, INC.

Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 20815634020843
• NIH Device Record Key: 10d321a2-d447-43e7-8659-1875a278a32f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTAMAX
• Version Model Number: AX-310
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815634020849 [Primary]
GS1	10815634020846 [Package]; Contains: 00815634020849; Package: SHELF BOX [5 Units]; In Commercial Distribution
GS1	20815634020843 [Package]; Contains: 10815634020846; Package: CASE [1 Units]; In Commercial Distribution

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

[20815634020843]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-19
• Device Publish Date: 2019-03-11

Devices Manufactured by MICROMEDICS, INC.

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• 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