Tianzi

GUDID 16935550813019

CONTROL SYRINGE 10ML LUER LOCK MALE TIP Rx only Sterile Non-toxic Non-pyrogenic

Jiangsu Shenli Medical Production Co.,Ltd.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 16935550813019
• NIH Device Record Key: 3d583138-b5fa-4578-8a7c-5d3b6136c665
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tianzi
• Version Model Number: 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06935550813012 [Primary]
GS1	16935550813019 [Package]; Contains: 06935550813012; Package: [25 Units]; In Commercial Distribution
GS1	26935550813016 [Package]; Package: [4 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: 2020-12-14
• Device Publish Date: 2020-12-05

On-Brand Devices [Tianzi]

• 16935550813019: CONTROL SYRINGE 10ML LUER LOCK MALE TIP Rx only Sterile Non-toxic Non-pyrogenic
• 06935550811018: Disposable needle 27G×1/2 Rx only Non-toxic Non-pyrogenic
• 16935550810117: Disposable syringe 20ML LUER LOCK Rx only Sterile Non-toxic Non-pyrogenic
• 16935550810032: DISPOSABLE SYRINGE 1ml Luer Lock Rx Only, Non-toxic, Non-pyrogenic, Sterile, Single use only, No
• 16935550812319: STERILE SYRINGE WITH NEEDLE FOR SINGLE USE 3ml Luer Lock 23G×1‘’, Rx Only, Non-toxic, Non-
• 16935550812012: STERILE SYRINGE WITH NEEDLE FOR SINGLE USE 1ml Luer Slip 25G×1‘’, Rx Only, Non-toxic, Non-