Model: A1910-4
DI: 00810117211387
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Dose Calibrator Vial 20mL
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cc163901-a929-439f-8106-0b4e1d4487a4
Distribution Status:
In Commercial Distribution
DUNS Number:
041668633
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810117211387
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38318
Name: Radionuclide source, quality assurance
Definition:
A naturally occurring, accelerator produced, or reactor produced radioactive isotope used as a source of radiation in a variety of quality assurance (QA) tests, e.g., markers, daily constancy test, accuracy tests, linearity test, radiation detector operation and calibration of analytical and radiation field instruments. A QA radionuclide source comes in a variety of physical forms, e.g., sealed source, plated/foil source, embedded source or contained radioactive liquids or gels. It may be selected for a particular QA use because of the radiation it emits (alpha particles, beta particles, neutrons, gamma rays, x-rays), its energy spectrum or physical half-life.
FDA Product Codes
IXD
Source, Calibration, Sealed, Nuclear