RADII

GUDID 06971564630146

Hangzhou Kailong Medical Instruments Co.,Ltd.

X-ray tube housing assembly, diagnostic

• Primary Device ID: 06971564630146
• NIH Device Record Key: 8162806c-04b5-4c61-8a03-d35ec52fc3f5
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADII
• Version Model Number: H2108
• Company DUNS: 529835089
• Company Name: Hangzhou Kailong Medical Instruments Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971564630146 [Primary]

FDA Product Code

• ITY: Assembly, Tube Housing, X-Ray, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-08-30
• Device Publish Date: 2018-04-18

On-Brand Devices [RADII]

• 06971564630146: H2108
• 06971564630139: H2107
• 06971564630122: H2106
• 06971564630115: H2103
• 06971564630108: H2100
• 06971564630092: H2092
• 06971564630085: H2090
• 06971564630078: H1086
• 06971564630061: H1083
• 06971564630054: H1080
• 06971564630047: H1077
• 06971564630030: H1076
• 06971564630023: H1075
• 06971564630016: H1074X