097277

GUDID 01858028005137

ACQUIRE MED

Urogenital surgical laser system beam guide, reusable

• Primary Device ID: 01858028005137
• NIH Device Record Key: 502080f2-1f46-48c7-9121-e7db98d52d43
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Q-940-RTR
• Catalog Number: 097277
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858028005138 [Primary]
GS1	01858028005137 [Package]; Contains: 00858028005138; Package: [5 Units]; In Commercial Distribution
GS1	02858028005136 [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: 4
• Public Version Date: 2018-11-15
• 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