IN12-194232002

GUDID 26932503533021

POM inner tuber，Needle Length 4mm，with metal cap 19G*4*2.3*200，Shroat stucture

Micro-Tech (Nanjing) Co., Ltd.

Submucosal injection needle

• Primary Device ID: 26932503533021
• NIH Device Record Key: 8ee5e383-f3e7-4e0b-935e-b42bc6229de1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: IN12-194232002
• Catalog Number: IN12-194232002
• Company DUNS: 530269083
• Company Name: Micro-Tech (Nanjing) 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932503533027 [Primary]
GS1	16932503533024 [Package]; Contains: 06932503533027; Package: box [10 Units]; In Commercial Distribution
GS1	26932503533021 [Package]; Contains: 16932503533024; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150434

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-10

Devices Manufactured by Micro-Tech (Nanjing) Co., Ltd.

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• 16932503515617 - Biliary Plastic Stent Set: 2026-03-30 TPU,Straight,7Fr,15cm working length with 1700mm introducer
• 16932503515624 - Biliary Plastic Stent Set: 2026-03-30 TPU,Straight,7Fr,18cm working length with 1700mm introducer
• 16932503515631 - Biliary Plastic Stent Set: 2026-03-30 TPU,Straight,8.5Fr,5cm working length with 2200mm introducer
• 16932503515648 - Biliary Plastic Stent Set: 2026-03-30 TPU,Straight,8.5Fr,7cm working length with 2200mm introducer
• 16932503515655 - Biliary Plastic Stent Set: 2026-03-30 TPU,Straight,8.5Fr,9cm working length with 2200mm introducer
• 16932503515662 - Biliary Plastic Stent Set: 2026-03-30 TPU,Straight,8.5Fr,12cm working length with 2200mm introducer
• 16932503515679 - Biliary Plastic Stent Set: 2026-03-30 TPU,Straight,8.5Fr,15cm working length with 2200mm introducer