ECLIPSE

GUDID 16935550810100

10mL Luer Lock Syringe SINGLE USE ONLY

Jiangsu Shenli Medical Production Co.,Ltd.

General-purpose syringe, single-use

• Primary Device ID: 16935550810100
• NIH Device Record Key: e1abea76-d221-4449-979a-ecdbe312dd8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECLIPSE
• Version Model Number: PRP2600-10ML
• Company DUNS: 420611311
• Company Name: Jiangsu Shenli Medical Production Co.,Ltd.
• 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: 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	06935550810103 [Primary]
GS1	16935550810100 [Package]; Contains: 06935550810103; Package: box [100 Units]; In Commercial Distribution
GS1	26935550810107 [Package]; Package: case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103830

FDA Product Code

• FMF: Syringe, Piston

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: 2022-03-21
• Device Publish Date: 2022-03-11

On-Brand Devices [ECLIPSE]

• 16935550817024: Eclipse Blood Collection Set SIZE:21G/19.5mm
• 16935550810100: 10mL Luer Lock Syringe SINGLE USE ONLY