AccessGUDID - DEVICE: PET DOSE DRAWING SYTEM (00718175004678)

GUDID

Device Identifier (DI) Information

Brand Name: PET DOSE DRAWING SYTEM
Version or Model: 042-467
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 042-467
Company Name: BIODEX MEDICAL SYSTEMS, INC.

Primary DI Number: 00718175004678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043833813 *Terms of Use

Device Description: Dose Drawing System, PET with L-Block

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?
40905	Radiation shielding container, general-purpose	A radiation protection device intended for hospital or clinic use that is specifically designed to shield persons from unintended radiation exposure to radioactive materials, sources, devices, and/or radiopharmaceuticals that are being kept in the facility. The design typically incorporates lead shielding or plastic materials of sufficient thickness to attenuate a specified level of radioactivity. This GMDN code does not include special purpose containers designed as vial or syringe shields or transportation/transfer containers.	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: a74a0a14-87b3-407c-abab-e00644a9c35a
Public Version Date: June 10, 2019
Public Version Number: 1
DI Record Publish Date: May 31, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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