SurgyNeedle 780-411

GUDID 00810014635101

5mm disposable aspiration needle, 15ga needle, 40cm length

U.S. SURGITECH INC.

Body aspiration needle, single-use

• Primary Device ID: 00810014635101
• NIH Device Record Key: ea7dcd82-12bb-42f7-9f4f-c90b7c1f4a6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgyNeedle
• Version Model Number: 780-411
• Catalog Number: 780-411
• Company DUNS: 142007082
• Company Name: U.S. SURGITECH INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: true
• 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	00810014635088 [Primary]
GS1	00810014635095 [Package]; Contains: 00810014635088; Package: Box [10 Units]; In Commercial Distribution
GS1	00810014635101 [Package]; Contains: 00810014635088; Package: Box [100 Units]; In Commercial Distribution

FDA Product Code

• GAA: Needle, Aspiration And Injection, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-12
• Device Publish Date: 2019-03-20

On-Brand Devices [SurgyNeedle]

• 00810014635132: 5mm disposable aspiration needle, 21ga needle, 40cm length
• 00810014635101: 5mm disposable aspiration needle, 15ga needle, 40cm length
• 00810014630281: 780-417
• 00810014630250: 780-416
• 00810014630120: 780-415
• 10810014630073: 780-414
• 10810014630066: 780-413