ZKSK

GUDID 06934415061605

Beijing ZKSK Technology Co.,Ltd

Oesophageal endoscopic ligator, single-use

• Primary Device ID: 06934415061605
• NIH Device Record Key: c27f0a03-b5ed-4a01-8e97-0f3cf5661210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZKSK
• Version Model Number: BL18-5M
• Company DUNS: 542947117
• Company Name: Beijing ZKSK Technology 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934415061605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213223

FDA Product Code

• FHN: Ligator, Hemorrhoidal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-28
• Device Publish Date: 2023-07-20

On-Brand Devices [ZKSK]

• 06934415066679: BL18-9A
• 06934415066662: BL18-7A
• 06934415066655: BL18-6A
• 06934415066648: BL18-5A
• 06934415066631: BL18-4A
• 06934415066624: BL18-8A
• 06934415061667: BL18-4M
• 06934415061650: BL18-9M
• 06934415061643: BL18-8M
• 06934415061636: BL18-7M
• 06934415061629: BL18-6M
• 06934415061605: BL18-5M
• 06934415088688: Disposable Pulse Lavage
• 06934415099912: Hood
• 06934415099882: Hood
• 06934415066587: Disposable Biopsy Forceps
• 06934415066570: Disposable Biopsy Forceps
• 06934415066563: Disposable Biopsy Forceps
• 06934415066556: Disposable Biopsy Forceps
• 06934415066549: Disposable Biopsy Forceps
• 06934415011235: Disposable Pulse Lavage
• 06934415011228: Disposable Pulse Lavage
• 06934415012072: Disposable Hemoclip
• 06934415012034: Disposable Hemoclip
• 06934415011266: Disposable Hemoclip
• 06934415011259: Disposable Hemoclip
• 06934415011242: Disposable Hemoclip
• 06934415011143: Disposable Hemoclip
• 06934415011129: Disposable Hemoclip
• 06934415011105: Disposable Hemoclip
• 06934415012164: Disposable Hemoclip
• 06934415012157: Disposable Hemoclip
• 06934415011150: Disposable Hemoclip
• 06934415011136: Disposable Hemoclip
• 06934415066693: Endoscopic Injection Needle
• 06934415066433: Endoscopic Injection Needle
• 06934415066686: Endoscopic Injection Needle
• 06934415066532: Endoscopic Injection Needle
• 06934415066525: Endoscopic Injection Needle
• 06934415066518: Endoscopic Injection Needle
• 06934415066495: SN18-09/160
• 06934415066488: Endoscopic Injection Needle
• 06934415066471: Endoscopic Injection Needle
• 06934415066464: Endoscopic Injection Needle
• 06934415066457: Endoscopic Injection Needle
• 06934415066402: Endoscopic Injection Needle
• 06934415066105: Disposable Polypectomy Snare
• 06934415022293: Disposable Hot Biopsy Forceps
• 06934415022286: Disposable Hot Biopsy Forceps
• 06934415022279: Disposable Hot Biopsy Forceps