FDA.report

PET UNIT DOSE

Primary DI
00718175001752
Brand
PET UNIT DOSE
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
001-785
Catalog number
001-785
Device description
Pig, Unit Dose, PET, 3/5 cc, .5" lead accommodates syringes with or without needle
Published
2018-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KPYShield, Protective, Personnel

Product Code Classifications

CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00718175001752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175001752007181750017527181750017520718175001752

GMDN Terms

TermDefinition
Radiation shielding container, transport/transferA radiation protection device specifically designed to shield persons from harmful radiation exposure during air or land based shipping, transfer and delivery of radioactive materials (e.g., radioisotopes) from facility to facility. Designs typically incorporate a container with a lead lining sufficient to attenuate the emissions from the contained radioactive materials, sources, radiopharmaceuticals, or radiation containing devices being transported. This device is used for intra- and inter-hospital transportation of syringes, vials or other devices containing radioisotopes.

Sterilization Methods

Method

Regulatory Flags

DUNS number
043833813
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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