AccessGUDID - DEVICE: SMARTFREEZE™ (00191506007737)

GUDID

Device Identifier (DI) Information

Brand Name: SMARTFREEZE™
Version or Model: M004CRBS6500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M004CRBS6500
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506007737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Remote Control

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?
65124	Cardiac cryosurgical system remote control	A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the operational functions of a cardiac cryosurgical system and its components (e.g., cardiac tissue ablation catheter) from a distance via a connected cable or wirelessly, during a surgical intervention. It is intended to be operated by the healthcare provider.	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: 23c0763d-62eb-4d0f-9762-2b19138b4d44
Public Version Date: August 29, 2023
Public Version Number: 1
DI Record Publish Date: August 21, 2023