AccessGUDID - DEVICE: IntellaTip MiFi™ Filter Module (08714729854395)

GUDID

Device Identifier (DI) Information

Brand Name: IntellaTip MiFi™ Filter Module
Version or Model: M0041212H0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729854395
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: RF Frequency Filter

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:	Yes
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
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020025	036
P020025	045
P020025	046
P020025	059
P020025	060
P020025	061
P020025	074
P020025	075

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: faaaab0c-8077-407b-ae05-5d00a8f26b66
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 08, 2016