SureClip ROCC-D-23-165

GUDID 26932503530013

Open width11±1mm the max OD of insertion part 2.3mm working length 1650mm uncoated

Micro-Tech (Nanjing) Co., Ltd.

Gastrointestinal endoscopic clip, short-term

• Primary Device ID: 26932503530013
• NIH Device Record Key: 7d7a97a5-1479-49a2-ad89-7a7eab40ec72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureClip
• Version Model Number: ROCC-D-23-165
• Catalog Number: ROCC-D-23-165
• Company DUNS: 530269083
• Company Name: Micro-Tech (Nanjing) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	06932503530019 [Primary]
GS1	16932503530016 [Package]; Contains: 06932503530019; Package: box [10 Units]; In Commercial Distribution
GS1	26932503530013 [Package]; Contains: 16932503530016; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152001

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-10

On-Brand Devices [SureClip]

• 26932503530389: Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm coated, single rota
• 26932503530372: Open width16±2mm the max OD of insertion part 2.6mm working length 1650mm coated, single rota
• 26932503530365: Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm coated,single rotati
• 26932503530358: Open width11±1mm the max OD of insertion part 2.6mm working length 1650mm coated, single rota
• 26932503530341: Open width+2/0mm the max OD of insertion part 2.6mm working length 2350mm coated, single rotati
• 26932503530334: Open width8+2/0mm the max OD of insertion part 2.6mm working length 1650mm coated, single rotat
• 26932503530327: Open width16±2mm the max OD of insertion part 2.6mm working length 2700mm coated
• 26932503530310: Open width16±2mm the max OD of insertion part 2.6mm working length 2700mm uncoated
• 26932503530303: Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm coated
• 26932503530297: Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm uncoated
• 26932503530280: Open width16±2mm the max OD of insertion part 2.6mm working length 1950mm coated
• 26932503530273: Open width16±2mm the max OD of insertion part 2.6mm working length 1950mm uncoated
• 26932503530266: Open width16±2mm the max OD of insertion part 2.6mm working length 1650mm coated
• 26932503530259: Open width16±2mm the max OD of insertion part 2.6mm working length 1650mm uncoated
• 26932503530242: Open width8±1mm the max OD of insertion part 2.6mm working length 2700mm coated
• 26932503530235: Open width8±1mm the max OD of insertion part 2.6mm working length 2700mm uncoated
• 26932503530228: Open width8±1mm the max OD of insertion part 2.6mm working length 2350mm coated
• 26932503530211: Open width8±1mm the max OD of insertion part 2.6mm working length 2350mm uncoated
• 26932503530204: Open width8±1mm the max OD of insertion part 2.6mm working length 1950mm coated
• 26932503530198: Open width8±1mm the max OD of insertion part 2.6mm working length 1950mm uncoated
• 26932503530181: Open width8±1mm the max OD of insertion part 2.6mm working length 1650mm coated
• 26932503530174: Open width8±1mm the max OD of insertion part 2.6mm working length 1650mm uncoated
• 26932503530167: Open width11±1mm the max OD of insertion part 2.6mm working length 2700mm coated
• 26932503530150: Open width11±1mm the max OD of insertion part 2.6mm working length 2700mm uncoated
• 26932503530143: Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm coated
• 26932503530136: Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm uncoated
• 26932503530129: Open width11±1mm the max OD of insertion part 2.6mm working length 1950mm coated
• 26932503530112: Open width11±1mm the max OD of insertion part 2.6mm working length 1950mm uncoated
• 26932503530105: Open width11±1mm the max OD of insertion part 2.6mm working length 1650mm coated
• 26932503530099: Open width11±1mm the max OD of insertion part 2.6mm working length 1650mm uncoated
• 26932503530082: Open width11±1mm the max OD of insertion part 2.3mm working length 2700mm coated
• 26932503530075: Open width11±1mm the max OD of insertion part 2.3mm working length 2700mm uncoated
• 26932503530068: Open width11±1mm the max OD of insertion part 2.3mm working length 2350mm coated
• 26932503530051: Open width11±1mm the max OD of insertion part 2.3mm working length 2350mm uncoated
• 26932503530044: Open width11±1mm the max OD of insertion part 2.3mm working length 1950mm coated
• 26932503530037: Open width11±1mm the max OD of insertion part 2.3mm working length 1950mm uncoated
• 26932503530020: Open width11±1mm the max OD of insertion part 2.3mm working length 1650mm coated
• 26932503530013: Open width11±1mm the max OD of insertion part 2.3mm working length 1650mm uncoated
• 66932503530387: Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in the
• 66932503530370: Open width16±2mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in the
• 66932503530363: Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in the
• 66932503530356: Open width11±1mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in the
• 66932503530349: Open width+2/0mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in the
• 66932503530332: Open width8+2/0mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in the
• 66932503530301: Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in the
• 66932503530264: Open width16±2mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in the
• 66932503530226: Open width8±1.5mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in th
• 66932503530189: Open width8±1.5mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in th
• 66932503530141: Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in the
• 66932503530103: Open width11±1mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in the