Acquire™ S M00555640

GUDID 00191506030766

Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

BOSTON SCIENTIFIC CORPORATION

General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use

• Primary Device ID: 00191506030766
• NIH Device Record Key: bdeea101-f4f2-4a6f-a8db-b5e95213ef1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acquire™ S
• Version Model Number: M00555640
• Catalog Number: M00555640
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: 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 Dimensions

• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506030742 [Primary]
GS1	00191506030766 [Package]; Contains: 00191506030742; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• ODG: Endoscopic ultrasound system, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-24
• Device Publish Date: 2024-05-16

On-Brand Devices [Acquire™ S]

• 00191506030773: Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
• 00191506030766: Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device