Lockado(TM) Repositionable Hemostasis Clip

GUDID 16932503530863

Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm coated, single pickling wire, 10 pcs in the box Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm coated, single pickling wire, 2 pcs in the box

Micro-Tech (Nanjing) Co., Ltd.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 16932503530863
• NIH Device Record Key: 305a48a5-5c8d-4c68-96a1-7cea0c276e76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lockado(TM) Repositionable Hemostasis Clip
• Version Model Number: LOCK-D-26-235-C-N
• 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: false
• 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	06932503530866 [Primary]
GS1	16932503530863 [Package]; Contains: 06932503530866; Package: BOX [10 Units]; In Commercial Distribution
GS1	26932503530860 [Package]; Package: CASE [10 Units]; In Commercial Distribution
GS1	56932503530861 [Package]; Contains: 06932503530866; Package: BOX [2 Units]; In Commercial Distribution
GS1	66932503530868 [Package]; Contains: 56932503530861; Package: CASE [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202333

FDA Product Code

• PKL: Hemostatic Metal Clip For The Gi Tract

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-10-11
• Device Publish Date: 2022-12-31

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

• 16932503520673 - Disposable Dilation Balloon: 2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1000mm,with
• 16932503520680 - Disposable Dilation Balloon: 2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1800mm,with
• 16932503520697 - Disposable Dilation Balloon: 2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 2400mm,with
• 16932503520765 - Disposable Dilation Balloon: 2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1000mm,with
• 16932503520772 - Disposable Dilation Balloon: 2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1800mm,with
• 16932503520789 - Disposable Dilation Balloon: 2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 2400mm,with
• 16932503534694 - Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB): 2025-05-08 Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel:
• 16932503534700 - Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA): 2025-05-08 Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: