Adler MicroMed Laster Surgery Fiber SFCS000101

GUDID 00850348007014

Adler MicroMed Laser Surgery Fiber 2.5 NC 400 RSCF 1.3

ADLER MICROMED, INC.

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00850348007014
• NIH Device Record Key: 01374a80-4fe5-4c62-a054-51293bcc34dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adler MicroMed Laster Surgery Fiber
• Version Model Number: SFCS000101
• Catalog Number: SFCS000101
• Company DUNS: 080298464
• Company Name: ADLER MICROMED, 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: true
• 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	00850348007014 [Primary]
GS1	00850348007076 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	00850348007137 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152417

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

[00850348007014]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-17

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