BEST-LISAS BSL0910

GUDID 18033959220488

Bone marrow biopsy needle 09G x 10cm

STERYLAB SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 18033959220488
• NIH Device Record Key: 0ec09521-20ea-42dd-84d9-cad49efa546a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEST-LISAS
• Version Model Number: BEST-LISAS
• Catalog Number: BSL0910
• 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	08033959220481 [Primary]
GS1	18033959220488 [Package]; Contains: 08033959220481; 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 [BEST-LISAS]

• 18033959222574: Bone marrow biopsy needle 13G x 9cm
• 18033959222567: Bone marrow biopsy needle 13G x 5cm
• 18033959220518: Bone marrow biopsy needle 11G x 15cm
• 18033959220501: Bone marrow biopsy needle 11G x 10cm
• 18033959220495: Bone marrow biopsy needle 09G x 15cm
• 18033959220488: Bone marrow biopsy needle 09G x 10cm