AccessGUDID - DEVICE: TransForm McCarthy Annuloplasty Ring (B040TF320)

GUDID

Device Identifier (DI) Information

Brand Name: TransForm McCarthy Annuloplasty Ring
Version or Model: TF-32
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENESEE BIOMEDICAL, INC.

Primary DI Number: B040TF320
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 939872651 *Terms of Use

Device Description: Annuloplasty Ring

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	Yes
For Single-Use:	Yes
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?
66338	Mitral/tricuspid annuloplasty ring, open-surgery	A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRH	Ring, Annuloplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232599	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: bf66b94d-afd9-4572-808c-a96742fafb98
Public Version Date: December 31, 2024
Public Version Number: 1
DI Record Publish Date: December 23, 2024