Capintec Dose Calibrator

GUDID 00859942006010

Radioisotope Dose Calibrator

CAPINTEC, INC.

Radioisotope calibration system

• Primary Device ID: 00859942006010
• NIH Device Record Key: df1d450a-4117-401d-a151-9986c24ccb08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capintec Dose Calibrator
• Version Model Number: CRC-55tPET
• Company DUNS: 047684501
• Company Name: CAPINTEC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859942006010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101452

FDA Product Code

• KPT: Calibrator, Dose, Radionuclide

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: 2018-07-06
• Device Publish Date: 2016-09-14

On-Brand Devices [Capintec Dose Calibrator]

• 00859942006089: Radioisotope Dose Calibrator
• 00859942006072: Radioisotope Dose Calibrator
• 00859942006065: Radioisotope Dose Calibrator
• 00859942006058: Radioisotope Dose Calibrator
• 00859942006041: Radioisotope Dose Calibrator
• 00859942006034: Radioisotope Dose Calibrator
• 00859942006027: Radioisotope Dose Calibrator
• 00859942006010: Radioisotope Dose Calibrator
• 00859942006003: Radioisotope Dose Calibrator