Safety Needle

GUDID 05907527942194

STERIPACK MEDICAL POLAND SP Z O O

Hypodermic needle, single-use

• Primary Device ID: 05907527942194
• NIH Device Record Key: f4e893ce-6454-48d3-8c75-5133fd93d684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safety Needle
• Version Model Number: Safety Needle 20Gx1 1/2
• Company DUNS: 522155365
• Company Name: STERIPACK MEDICAL POLAND SP Z O O
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05907527942194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012736

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-11
• Device Publish Date: 2018-10-22

On-Brand Devices [Safety Needle]

• 05907527942194: Safety Needle 20Gx1 1/2
• 05907527942095: Safety Needle 22Gx1 1/2
• 05907527942088: Safety Needle 22Gx1
• 05907527942033: Safety Needle 22Gx1 1/2
• 05907527942026: Safety Needle 23Gx1
• 05907527942187: 7527942187
• 05907527942071: 7527942071
• 05907527942064: 7527942064
• 05907527942019: 7527942019
• 05907527942002: 7527942002