Adler MircroMed Laser Surgery Fiber BFCS000288

GUDID 00850348007205

Adler MircroMed laser Surgery Fiber 3.0 NC 270 HGT 420

ADLER MICROMED, INC.

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00850348007205
• NIH Device Record Key: db2d5ee9-65bf-41ff-aa4c-5aea1a2c13a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adler MircroMed Laser Surgery Fiber
• Version Model Number: BFCS000288
• Catalog Number: BFCS000288
• 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	00850348007182 [Primary]
GS1	00850348007199 [Package]; Contains: 00850348007182; Package: [5 Units]; In Commercial Distribution
GS1	00850348007205 [Package]; Contains: 00850348007182; 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

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-09
• Device Publish Date: 2018-07-09

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