AccessGUDID - DEVICE: Medical Physicist Kit (M097MPK00021)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Physicist Kit
Version or Model: MPK-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPK-0002
Company Name: BEST VASCULAR, INC.

Primary DI Number: M097MPK00021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789032039 *Terms of Use

Device Description: Medical Physicist Kit for Novoste Beta-Cath System

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):	Yes
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?
61708	Manual-afterloading brachytherapy system utility kit	A collection of non-sterile devices intended to be used with a manual-afterloading brachytherapy system to provide various additional functions including: fluid sampling for subsequent assessment of transferable radioactive contamination, dry/store components, facilitate locating and handling a radioactive source. It includes single-use items such as syringes, collection bags, Luer caps, adaptors/connectors, and/or reusable items such as system containers, flashlight, source recovery probe, magnifying glass, tweezers, appropriate to the functions it is intended to perform.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOU	Intravascular Radiation Delivery System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000018	000

Device Exempt from Premarket Submission: No 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: 985fca90-694d-41dc-98bc-afa3563fa3cf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 10, 2015

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 770-717-0904
Email: xx@xx.xx

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