PARAGON PAG1115

GUDID 18033959222222

hematobiopsy needle 11 G 15cm

STERYLAB SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 18033959222222
• NIH Device Record Key: 2be011bf-586d-40ad-93fb-e283eb8aad29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARAGON
• Version Model Number: PARAGON
• Catalog Number: PAG1115
• 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	08033959222225 [Primary]
GS1	18033959222222 [Package]; Contains: 08033959222225; Package: [10 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 [PARAGON]

• 18033959226497: hematobiopsy needle 13G 9cm
• 18033959226480: hematobiopsy needle 13 G 5 cm
• 18033959222222: hematobiopsy needle 11 G 15cm
• 18033959222215: hematobiopsy needle 11G 10cm
• 18033959222208: hematobiopsy needle 9G 15cm
• 18033959222192: hematobiopsy needle 9G 10cm