IceRod™ H7493968535330

GUDID 00191506055776

Cryoablation Needle

BOSTON SCIENTIFIC CORPORATION

Cryosurgical set

• Primary Device ID: 00191506055776
• NIH Device Record Key: 64234e40-d72b-4bfe-846c-f278b4e7b6be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IceRod™
• Version Model Number: H7493968535330
• Catalog Number: H7493968535330
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter
• Needle Gauge: 17 Gauge
• Length: 175 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506055776 [Primary]

FDA Product Code

• GEH: UNIT, CRYOSURGICAL, ACCESSORIES

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: 2025-02-27
• Device Publish Date: 2025-02-19

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 00191506046361 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046378 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046385 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046392 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046408 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter