Gel Pad ASSY SET999014

GUDID 07290015461085

Transmission gel pad for single Body treatment. shipped in the following thickness (height) variants: Description Catalogue Number GEL PAD UF 25MM ASSY ASM000352-AA GEL PAD 15MM ASSY ASM000830-AA GEL PAD 40MM ASSY(Step) ASM002213 GEL PAD 45MM ASSY(Bowl) ASM000504-AA

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07290015461085
• NIH Device Record Key: 22548ae2-0d04-48fd-8b1d-a689c96806c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gel Pad ASSY
• Version Model Number: Gel Pad ASSY
• Catalog Number: SET999014
• Company DUNS: 532169513
• Company Name: INSIGHTEC LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18663922528
• Email: info@insightec.com

Device Dimensions

• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015461085 [Primary]

FDA Product Code

• LSY: Ultrasound,Hyperthermia, Cancer Treatment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-06-07

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