Needle, hypodermic, single lumen

GUDID 00858641006031

LIFE SCIENCE OUTSOURCING, INC.

Hypodermic needle, single-use

• Primary Device ID: 00858641006031
• NIH Device Record Key: 0bc0185a-72b3-40c0-81f1-e3001c6f0e34
• Commercial Distribution Discontinuation: 2020-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Needle, hypodermic, single lumen
• Version Model Number: 19B
• Company DUNS: 017149456
• Company Name: LIFE SCIENCE OUTSOURCING, INC.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858641006031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972538

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: 7
• Public Version Date: 2020-02-07
• Device Publish Date: 2016-05-03

Devices Manufactured by LIFE SCIENCE OUTSOURCING, INC.

• 00858641006000 - Set, IV, Fluid Transfer: 2020-02-10
• 00858641006017 - Set, IV, Fluid Transfer: 2020-02-10
• 00858641006024 - Syringe, Piston: 2020-02-10
• 00858641006048 - Ser, administration, intravascular: 2020-02-10
• 00858641006055 - Set, i.V. Fluid Transfer: 2020-02-10
• 00858641006079 - Set, Administration, Intravascular: 2020-02-10
• 00858641006086 - Set, I.V. Fluid Transfer: 2020-02-10
• 00858641006093 - Set, Administration, Intravascular: 2020-02-10