AccessGUDID - DEVICE: EP Recording Catheter (00811331011852)

GUDID

Device Identifier (DI) Information

Brand Name: EP Recording Catheter
Version or Model: CF-D7-AAA-NSDA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tz Medical, Inc.

Primary DI Number: 00811331011852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793149709 *Terms of Use

Device Description: EP Recording Catheter 14 pole, fixed curve

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:	Yes
Prescription Use (Rx):	No
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?
48015	Cardiac mapping/endocardial-injection catheter	A sterile, steerable, thin, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to relay information to an external cardiac mapping system to create a three-dimensional (3-D) electromechanical reconstruction map of the heart chamber. The device also incorporates a small hollow needle intended for targeted delivery of diagnostic and therapeutic agents into the myocardium. The device is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021421	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: f0b3435b-05f1-435c-b4e1-3e14e6cb87d0
Public Version Date: September 29, 2023
Public Version Number: 1
DI Record Publish Date: September 21, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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