GUDID 16959664941925

the Catheter OD is 2.4mm, working length is 2300mm, model of needle is 25, needle extension length is 4 mm, the headend type is metal cap

Hangzhou AGS MedTech Co., Ltd.

General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use

• Primary Device ID: 16959664941925
• NIH Device Record Key: b82ea43b-f7ad-4537-802d-0c24705bc8a9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AG-5313-2423-2504M
• Company DUNS: 542984702
• Company Name: Hangzhou AGS MedTech 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06959664941928 [Primary]
GS1	16959664941925 [Package]; Contains: 06959664941928; Package: Box [10 Units]; In Commercial Distribution
GS1	26959664941922 [Package]; Package: Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190032

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

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: 2021-12-14
• Device Publish Date: 2021-12-06

Devices Manufactured by Hangzhou AGS MedTech Co., Ltd.

• 16959664911959 - NA: 2023-04-10
• 16959664911966 - NA: 2023-04-10
• 16959664913496 - NA: 2023-04-10
• 16959664934279 - NA: 2023-04-10
• 16959664934316 - NA: 2023-04-10
• 16959664902087 - NA: 2022-10-20
• 16959664902100 - NA: 2022-10-20
• 16959664902162 - NA: 2022-10-20