AccessGUDID - DEVICE: SMARTFREEZE™ (08714729992738)

GUDID

Device Identifier (DI) Information

Brand Name: SMARTFREEZE™
Version or Model: M004CRBS4110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M004CRBS4110
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729992738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Inter-Connection Box

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?
35041	Electrosurgical cable adaptor	A small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220032	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: 82926460-5594-41f8-b443-20dbfc565785
Public Version Date: August 29, 2023
Public Version Number: 1
DI Record Publish Date: August 21, 2023