AccessGUDID - DEVICE: Temporary Storage Container (M097TSC00010)

GUDID

Device Identifier (DI) Information

Brand Name: Temporary Storage Container
Version or Model: TSC-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSC-0001
Company Name: BEST VASCULAR, INC.

Primary DI Number: M097TSC00010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789032039 *Terms of Use

Device Description: Temporary Storage Container 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?
61710	Manual-afterloading brachytherapy system storage container	A non-sterile radiation-shielding plastic box intended to store a manual-afterloading brachytherapy system. It is typically temporarily used as a safety container to prevent radiation leakage in the event of procedural difficulties.	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: 669ef346-2fcb-49e4-9314-23bf8f0cc490
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 10, 2015