Adler MicroMed Laser Surgery Fiber SFCS000145

GUDID 00850348007038

Adler MicroMed Laser Surgery Fiber 2.5 NC 600 FSC 1.8

ADLER MICROMED, INC.

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00850348007038
• NIH Device Record Key: 520e1c22-feea-42af-a8f4-3c754ade9964
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adler MicroMed Laser Surgery Fiber
• Version Model Number: SFCS000145
• Catalog Number: SFCS000145
• 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	00850348007038 [Primary]
GS1	00850348007090 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	00850348007151 [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

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

Ethylene Oxide

[00850348007038]

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

On-Brand Devices [Adler MicroMed Laser Surgery Fiber]

• 00850348007304: Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8
• 00850348007274: Adler MicroMed Laser Surgery Fiber 2.5 NC 400 T 750
• 00850348007267: Adler MicroMed Laser Surgery Luer Lock 600 NA 0.37 2.5m
• 00850348007236: Adler MicroMed Laser Surgery Fiber 3.0 NC 270 HGT 420 RT
• 00850348007052: Adler MicroMed Laser Surgery Fiber 2.5 NC 360 BT 395
• 00850348007038: Adler MicroMed Laser Surgery Fiber 2.5 NC 600 FSC 1.8
• 00850348007021: Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8
• 00850348007007: Adler MicroMed Laser Surgery Fiber 2.5 NC 600 RSCF 1.8
• 00850348007380: Adler MicroMed Laser Surgery Fiber 2.5 NC 600 RSCF 1.8
• 00850348007533: Adler MicroMed Laser Surgery Fiber 3.0 NC 270 GT 420 RT
• 00850348007502: Adler MicroMed Laser Surgery Fiber 2.5 NC 400 T 750
• 00850348007472: Adler MicroMed Laser Surgery Luer Lock Fiber 600 um NA 0.37 2.5m
• 00850348007441: Adler MicroMed Laser Surgery Fiber 3.0 NC 270 HGT 420
• 00850348007410: Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8