Capintec Dose Calibrator 5130-20254

GUDID 00859942006089

Radioisotope Dose Calibrator

CAPINTEC, INC.

Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system Radioisotope calibration system

• Primary Device ID: 00859942006089
• NIH Device Record Key: 0ae3f68d-13a2-4804-8310-fe22909c9169
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capintec Dose Calibrator
• Version Model Number: CRC-PC Smart Chamber RPh Chamber
• Catalog Number: 5130-20254
• 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	00859942006089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141413

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

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