AccessGUDID - DEVICE: LATITUDE® Communicator with Wand (00802526480485)

GUDID

Device Identifier (DI) Information

Brand Name: LATITUDE® Communicator with Wand
Version or Model: 6481
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00802526480485
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106295384 *Terms of Use

Device Description: LATITUDE ® Communicator with Wand

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?
42259	Multi-hole nuclear medicine system collimator, high-energy	A device designed specifically for use in gamma camera or single photon emission computed tomography (SPECT) based planar positron imaging applications operating with an energy range above 500 kilo-electronvolt (keV). It consists of an array of small openings drilled or cast into a flat sheet or plate of lead or lead-equivalent materials. Its size and shape is intended to conform to the crystal shape of a nuclear medicine imaging system to ensure that only gamma ray activity directly in front of the collimator channels in the array reaches the scintillation. It has attachment mechanisms that enable it to be safely transported, removed from, and attached to the detector head of the system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWS	Implantable cardioverter defibrillator (non-CRT)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P910077	123

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: fb6e8752-6faa-4088-a903-197555acea8c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014