Disposable Injection Needles

GUDID 16942067960488

Disposable Injection Needles

Ningbo Xinwell Medical Technology Co., Ltd.

Submucosal injection needle

• Primary Device ID: 16942067960488
• NIH Device Record Key: b7c5a00c-9145-4a1e-b873-6fac3fcef170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Injection Needles
• Version Model Number: XY-ZSZ-C-23×2300×25×6
• Company DUNS: 544587864
• Company Name: Ningbo Xinwell Medical 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942067960481 [Primary]
GS1	16942067960488 [Package]; Contains: 06942067960481; Package: BOX [10 Units]; In Commercial Distribution
GS1	26942067960485 [Package]; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232200

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-13
• Device Publish Date: 2024-06-05

On-Brand Devices [Disposable Injection Needles]

• 16942067959048: Disposable Injection Needles
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• 16942067960501: Disposable Injection Needles
• 16942067960495: Disposable Injection Needles
• 16942067960488: Disposable Injection Needles
• 16942067960471: Disposable Injection Needles
• 16942067960464: Disposable Injection Needles
• 16942067960457: Disposable Injection Needles
• 16942067960440: Disposable Injection Needles
• 16942067960433: Disposable Injection Needles
• 16942067960426: Disposable Injection Needles
• 16942067960419: Disposable Injection Needles
• 16942067960402: Disposable Injection Needles
• 16942067960396: Disposable Injection Needles
• 16942067960389: Disposable Injection Needles
• 16942067960372: Disposable Injection Needles
• 16942067960365: Disposable Injection Needles
• 16942067960358: Disposable Injection Needles
• 16942067960341: Disposable Injection Needles
• 16942067960334: Disposable Injection Needles
• 16942067960327: Disposable Injection Needles
• 16942067960310: Disposable Injection Needles
• 16942067960303: Disposable Injection Needles
• 16942067960297: Disposable Injection Needles
• 16942067960280: Disposable Injection Needles
• 16942067960273: Disposable Injection Needles
• 16942067960266: Disposable Injection Needles
• 16942067960259: Disposable Injection Needles
• 16942067960242: Disposable Injection Needles
• 16942067960235: Disposable Injection Needles
• 16942067960228: Disposable Injection Needles
• 16942067960211: Disposable Injection Needles
• 16942067960204: Disposable Injection Needles
• 16942067960198: Disposable Injection Needles
• 16942067960181: Disposable Injection Needles
• 16942067960174: Disposable Injection Needles
• 16942067960167: Disposable Injection Needles
• 16942067960150: Disposable Injection Needles
• 16942067960143: Disposable Injection Needles
• 16942067960136: Disposable Injection Needles
• 16942067960129: Disposable Injection Needles
• 16942067960112: Disposable Injection Needles
• 16942067960105: Disposable Injection Needles
• 16942067960099: Disposable Injection Needles
• 16942067960082: Disposable Injection Needles
• 16942067960075: Disposable Injection Needles
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• 16942067960051: Disposable Injection Needles
• 16942067960044: Disposable Injection Needles
• 16942067960037: Disposable Injection Needles