BEN BEN0815

GUDID 18033959220532

Bone marrow biopsy needle, Trocar point, 8G x 15cm

STERYLAB SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 18033959220532
• NIH Device Record Key: 0f698856-7181-45d2-bcb5-d34a4d4e1003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEN
• Version Model Number: BEN
• Catalog Number: BEN0815
• Company DUNS: 439659574
• Company Name: STERYLAB SRL
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033959220535 [Primary]
GS1	18033959220532 [Package]; Contains: 08033959220535; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

FDA Product Code

• KNW: Instrument, Biopsy

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: 2019-10-10
• Device Publish Date: 2019-10-02

On-Brand Devices [BEN]

• 18033959220563: Bone marrow biopsy needle, Trocar point, 13G x 09cm
• 18033959220556: Bone marrow biopsy needle, Trocar point, 11G x 15cm
• 18033959220549: Bone marrow biopsy needle, Trocar point, 11G x 10cm
• 18033959220532: Bone marrow biopsy needle, Trocar point, 8G x 15cm
• 18033959220525: Bone marrow biopsy needle, Trocar point, 8G x 10cm