IN12-254232302

GUDID 26932503533212

POM inner tuber，Needle Length 4mm，with metal cap 25G*4*2.3*230，Shroat stucture

Micro-Tech (Nanjing) Co., Ltd.

Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle

• Primary Device ID: 26932503533212
• NIH Device Record Key: 78dde19c-3b0c-4541-af0f-ac26f779465c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: IN12-254232302
• Catalog Number: IN12-254232302
• 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	06932503533218 [Primary]
GS1	16932503533215 [Package]; Contains: 06932503533218; Package: box [10 Units]; In Commercial Distribution
GS1	26932503533212 [Package]; Contains: 16932503533215; 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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• 16932503513705 - MT: 2023-12-08 TPU, Double pigtails,7Fr,5cm
• 16932503513712 - MT: 2023-12-08 TPU, Double pigtails,7Fr,7cm
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• 16932503513736 - MT: 2023-12-08 TPU, Double pigtails,7Fr,12cm
• 16932503513743 - MT: 2023-12-08 TPU, Double pigtails,7Fr,15cm
• 16932503513750 - MT: 2023-12-08 TPU, Double pigtails,8.5Fr,3cm