ECTphan™ 330 SMR330

GUDID 00812266030598

ECTphan™ 330, Complete ECTphan™ included, MTF point source holder and 3SMR341 low contrast inserts and cantilever case mounting system

Providus Holdings, Inc.

Multi-modality diagnostic imaging phantom, test object

• Primary Device ID: 00812266030598
• NIH Device Record Key: 36eee4da-65f5-4bda-b32b-bc9a8041f3fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECTphan™ 330
• Version Model Number: SMR330
• Catalog Number: SMR330
• Company DUNS: 104162493
• Company Name: Providus Holdings, Inc.
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812266030598 [Primary]

FDA Product Code

• IXF: Test-Pattern, Radiographic

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: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by Providus Holdings, Inc.

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• 00812266030765 - LiquiPhil™: 2024-05-15 PTW Pinpoint Chamber Adapter
• 00812266030772 - LiquiPhil™: 2024-05-15 LiquiPhil™ End-to-End Pelvis, includes pelvis form, two 10cm ovoid tumor vessels and permanent storage case
• 00812266030789 - LiquiPhil™: 2024-05-15 Optional Tumor Vessel Assembly, 10cm Tumor Vessel Assembly includes 10cm x 12cm threaded 10cm Tumor Vessel Assembly includes 10c
• 00812266030796 - LiquiPhil™: 2024-05-15 LiquiPhil™ End-to-End Half Sphere Phantom, Includes chamber mount for A116.
• 00812266030802 - LiquiPhil™: 2024-05-15 Optional PTW31030 Chamber Mount
• 00812266030697 - LiquiPhil™: 2024-05-13 Hollow Tumors, Combination Sets of Spherical and Ovoid, Combination set of six hollow tumors
• 00812266030703 - LiquiPhil™: 2024-05-13 Combination set of nine hollow tumors with one each of the following sizes: Spherical: 1cm, 1.5cm, 2cm, 3cm Ovoid: 1.5cm x 3cm l