AccessGUDID - DEVICE: LABSYSTEM™ PRO (08714729882961)

GUDID

Device Identifier (DI) Information

Brand Name: LABSYSTEM™ PRO
Version or Model: M00420012300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729882961
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: RF Filter Module For CLEARSIGN™ Amplifier

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?
36806	Electronic signal frequency filter	An electronic filter that transfers electronic signals at all frequencies within a certain area, and suppresses signals at all other frequencies outside this area. This GMDN code also includes octave and third-octave filters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRQ	AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 663de6db-6d8e-400f-82b1-a25735deb8bc
Public Version Date: October 24, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016