triton 09000

GUDID 00863897000351

tube mount, x-ray, diagnostic PVGD

CORE LABS, LLC

X-ray system tube support, floor stand X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing X-ray system tube support, floor standing

• Primary Device ID: 00863897000351
• NIH Device Record Key: cdd23edb-02a5-45a4-845d-ece3f2f3cb19
• Commercial Distribution Discontinuation: 2099-10-04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: triton
• Version Model Number: 09000
• Catalog Number: 09000
• Company DUNS: 622766397
• Company Name: CORE LABS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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	00863897000351 [Primary]

FDA Product Code

• IYB: Tube Mount, 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: 3
• Public Version Date: 2019-09-10
• Device Publish Date: 2017-11-17

Devices Manufactured by CORE LABS, LLC

• 00863897000344 - halo: 2019-09-10 tube mount, x-ray, diagnostic HQNR
• 00863897000351 - triton: 2019-09-10tube mount, x-ray, diagnostic PVGD
• 00863897000351 - triton: 2019-09-10 tube mount, x-ray, diagnostic PVGD
• 00863897000306 - atlas: 2018-03-29 Elevating Radiographic Patient Table HXVF
• 00863897000313 - aries: 2018-03-29 Non-Elevating Radiographic Patient Table HXVF
• 00863897000320 - aries: 2018-03-29 Non-Elevating Radiographic Patient Table HXVF
• 00863897000368 - flora: 2018-03-29 Radiographic Wall Cassette Holder XDTG