AccessGUDID - DEVICE: HAART (10857160006239)

GUDID

Device Identifier (DI) Information

Brand Name: HAART
Version or Model: 200-19US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200-19US
Company Name: Corcym Inc.

Primary DI Number: 10857160006239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112833663 *Terms of Use

Device Description: Aortic 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":	No
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?
47931	Aortic annuloplasty ring	A circular band intended to be implanted in the heart during open heart surgery to support an aortic valve annulus for the reconstruction and/or remodelling of an insufficient aortic valve. It is typically mounted on a disposable holder assembly to enable it to maintain its shape and aid in its implantation, which may involve a specialized handle, with sutures. 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
PST	Aortic Annuloplasty Ring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171431	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: 2f2ea065-224b-4925-b723-88243f9f7196
Public Version Date: June 19, 2023
Public Version Number: 6
DI Record Publish Date: September 27, 2017

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

[?]

Phone: 512-970-9112
Email: julie.thomas@biostable-s-e.com

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