HBF55-11023180

GUDID 26932503548513

Oval, without spike, 2.3*1800 mm

Micro-Tech (Nanjing) Co., Ltd.

Flexible endoscopic biopsy forceps, single-use

• Primary Device ID: 26932503548513
• NIH Device Record Key: 0d9a47ca-514f-48fe-b1d6-5fe2e3052833
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HBF55-11023180
• Catalog Number: HBF55-11023180
• 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	06932503548519 [Primary]
GS1	16932503548516 [Package]; Contains: 06932503548519; Package: box [10 Units]; In Commercial Distribution
GS1	26932503548513 [Package]; Contains: 16932503548516; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160625

FDA Product Code

• KGE: Forceps, Biopsy, Electric

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: 2016-07-01

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

• 16932503511169 - MT: 2024-08-14 Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 12mm/15mm, Working Length 2000mm,
• 16932503511176 - MT: 2024-08-14 Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 15mm/18mm, Working Length 2000mm,
• 16932503511183 - MT: 2024-08-14 Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 18mm/21mm, Working Length 2000mm,
• 16932503511190 - MT: 2024-08-14 Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 9mm/12mm/15mm, Working Length 2000mm,
• 16932503511206 - MT: 2024-08-14 Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 12mm/15mm/18mm, Working Length 2000mm,
• 16932503511213 - MT: 2024-08-14 Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 15mm/18mm/21mm, Working Length 2000mm,
• 16932503511220 - MT: 2024-08-14 Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 9mm/12mm, Working Length 2000mm,
• 16932503511237 - MT: 2024-08-14 Sterile Biliary Stone Retrieval Balloon Catheter with triple-lumen, Work diameter 12mm/15mm, Working Length 2000mm,