S Spellman High Voltage Electronics Corporation

GUDID 06975490630362

X-ray high voltage generator, 409085-001

Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd

Diagnostic x-ray system generator, stationary

• Primary Device ID: 06975490630362
• NIH Device Record Key: 4fa4249b-255d-4b55-b1c3-f81ebc5104a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S Spellman High Voltage Electronics Corporation
• Version Model Number: 409085-001
• Company DUNS: 529124841
• Company Name: Spellman High Voltage Electronics(Suzhou Industrial Park) 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975490630362 [Primary]

FDA Product Code

• IZO: Generator, High-Voltage, X-Ray, Diagnostic

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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [S Spellman High Voltage Electronics Corporation]

• 06975490630362: X-ray high voltage generator, 409085-001
• 06975490630355: ZR75PN40S, Without console
• 06975490630348: ZR75PN40S, Mini console with handswitch
• 06975490630331: ZR75PN40S, Mini console without handswitch
• 06975490630324: ZR75PN40S, Touch screen console without handswitch
• 06975490630317: ZR75PN40S, Touch screen console with handswitch
• 06975490630300: ZR75PN32S, Without console
• 06975490630294: ZR75PN32S, Mini console with handswitch
• 06975490630287: ZR75PN32S, Mini console without handswitch
• 06975490630270: ZR75PN32S, Touch screen console without handswitch
• 06975490630263: ZR75PN32S, Touch screen console with handswitch
• 06975490630256: ZR75PN80, Without console
• 06975490630249: ZR75PN80, Mini console with handswitch
• 06975490630232: ZR75PN80, Mini console without handswitch
• 06975490630225: ZR75PN80, Touch screen console without handswitch
• 06975490630218: ZR75PN80, Touch screen console with handswitch
• 06975490630201: ZR75PN65, Without console
• 06975490630195: ZR75PN65, Mini console without handswitch
• 06975490630188: ZR75PN65, Touch screen console without handswitch
• 06975490630171: ZR75PN65, Touch screen console with handswitch
• 06975490630164: ZR75PN50, Without console
• 06975490630157: ZR75PN50, Mini console with handswitch
• 06975490630140: ZR75PN50, Mini console without handswitch
• 06975490630133: ZR75PN50, Touch screen console without handswitch
• 06975490630126: ZR75PN50, Touch screen console with handswitch
• 06975490630119: ZR75PN40, Without console
• 06975490630102: ZR75PN40, Mini console with handswitch
• 06975490630096: ZR75PN40, Mini console without handswitch
• 06975490630089: ZR75PN40, Touch screen console without handswitch
• 06975490630072: ZR75PN40, Touch screen console with handswitch
• 06975490630065: ZR75PN32, Without console
• 06975490630058: ZR75PN32, Mini console with handswitch
• 06975490630041: ZR75PN32, Mini console without handswitch
• 06975490630034: ZR75PN32, Touch Screen console without handswitch
• 06975490630027: ZR75PN32, Touch screen console with handswitch
• 06975490630010: ZR75PN65, Mini console with handswitch