096656

GUDID 01858028005038

ACQUIRE MED

Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 01858028005038
• NIH Device Record Key: 30fbf35c-53c6-49ee-9062-9a8c9203866c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Q-365-RT
• Catalog Number: 096656
• Company DUNS: 061766352
• Company Name: ACQUIRE MED
• 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	00858028005039 [Primary]
GS1	01858028005038 [Package]; Contains: 00858028005039; Package: [5 Units]; In Commercial Distribution
GS1	02858028005037 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050738

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

Devices Manufactured by ACQUIRE MED

• 02816901023448 - Acquire Med: 2023-06-05
• 02816901022984 - Acquire Med: 2021-06-22
• 02816901022816 - LEONI™: 2021-06-09
• 02816901022823 - Acquire Med: 2021-06-09
• 01816901022831 - Acquire Med: 2021-06-09
• 02816901022847 - Acquire Med: 2021-06-09
• 01816901022855 - Acquire Med: 2021-06-09
• 01858028005083 - NA: 2018-11-15