Single-use Fine Needle Biopsy (FNB) Device NA-U210H N6221530

GUDID 14953170459310

OLYMPUS MEDICAL SYSTEMS CORP.

General-purpose endoscopic needle, single-use

• Primary Device ID: 14953170459310
• NIH Device Record Key: 381d2d89-4600-492c-a3b9-1ba88d9fd762
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Fine Needle Biopsy (FNB) Device NA-U210H
• Version Model Number: NA-U210H-8025
• Catalog Number: N6221530
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Dimensions

• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170459313 [Primary]
GS1	14953170459310 [Package]; Contains: 04953170459313; Package: [1 Units]; In Commercial Distribution
GS1	54953170459318 [Package]; Package: [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252646

FDA Product Code

• FCG: Biopsy Needle

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: 2025-12-10
• Device Publish Date: 2025-12-02

On-Brand Devices [Single-use Fine Needle Biopsy (FNB) Device NA-U210H]

• 14953170459310: NA-U210H-8025
• 14953170459259: NA-U210H-8022
• 14953170459204: NA-U210H-8019