BTT BTT1109

GUDID 18033959221737

bone-marrow trasplantation needle 11G 9 cm

STERYLAB SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 18033959221737
• NIH Device Record Key: 52d3ff09-ff17-4780-a60a-c5007b4bc0b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTT
• Version Model Number: BTT
• Catalog Number: BTT1109
• 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	08033959221730 [Primary]
GS1	18033959221737 [Package]; Contains: 08033959221730; Package: [5 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 [BTT]

• 18033959222604: bone-marrow trasplantation needle 13G 11 cm
• 08033959222287: bone-marrow trasplantation needle 13G 7 cm
• 18033959221744: bone-marrow trasplantation needle 11G 13 cm
• 18033959221737: bone-marrow trasplantation needle 11G 9 cm