AccessGUDID - DEVICE: PET UNIT DOSE (00718175001752)

GUDID

Device Identifier (DI) Information

Brand Name: PET UNIT DOSE
Version or Model: 001-785
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001-785
Company Name: BIODEX MEDICAL SYSTEMS, INC.

Primary DI Number: 00718175001752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043833813 *Terms of Use

Device Description: Pig, Unit Dose, PET, 3/5 cc, .5" lead accommodates syringes with or without needle

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40903	Radiation shielding container, transport/transfer	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPY	Shield, Protective, Personnel

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cfc29a51-5419-4ac7-8d6c-0674faed71ed
Public Version Date: January 15, 2019
Public Version Number: 1
DI Record Publish Date: December 15, 2018