BEST-LISAS DUAL BSL1309D

GUDID 18033959228217

Bone marrow biopsy needle 13G x 9cm

STERYLAB SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 18033959228217
• NIH Device Record Key: 1d57813b-8685-4315-8154-e83e42ae51af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEST-LISAS DUAL
• Version Model Number: BEST-LISAS DUAL
• Catalog Number: BSL1309D
• 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	08033959228210 [Primary]
GS1	18033959228217 [Package]; Contains: 08033959228210; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

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

On-Brand Devices [BEST-LISAS DUAL]

• 18033959228217: Bone marrow biopsy needle 13G x 9cm
• 18033959228200: Bone marrow biopsy needle 13G x 5cm
• 18033959228194: Bone marrow biopsy needle 11G x 15cm
• 18033959228187: Bone marrow biopsy needle 11G x 10cm
• 18033959228170: Bone marrow biopsy needle 09G x 15cm
• 18033959228163: Bone marrow biopsy needle 09G x 10cm