AccessGUDID - DEVICE: Alpha VI 40mm Transfer Device (M097TDA20400)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha VI 40mm Transfer Device
Version or Model: TDA-2040
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TDA-2040
Company Name: BEST VASCULAR, INC.

Primary DI Number: M097TDA20400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789032039 *Terms of Use

Device Description: Alpha VI 40mm Transfer Device for the 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?
61706	Manual-afterloading brachytherapy system source transfer device	A portable, battery-powered, hydraulically-operated, hand-held device intended to store and deliver/remove a therapeutic or palliative radiation dose to/from an anatomical region. It is designed to temporarily or permanently place a radioactive source on/in the treatment site through a connected applicator (e.g., coronary artery catheter) that has been previously introduced in the patient, and typically includes a sensor to monitor the position of the radioactive source. This is a reusable device.	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
P000018	015
P000018	035

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
Handling Environment Temperature: between 15 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90578160-9f70-419d-9fc2-8f591384aa61
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 10, 2015