AccessGUDID - DEVICE: Coronary Bypass Marker (B776106961)

GUDID

Device Identifier (DI) Information

Brand Name: Coronary Bypass Marker
Version or Model: Rev1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-696
Company Name: FIRST CALL, INC.

Primary DI Number: B776106961
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 015526185 *Terms of Use

Device Description: Suturing Washer

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?
60866	Metallic coronary bypass marker	A device intended to be implanted during coronary artery bypass graft surgery, at the point of the arterial anastomosis, to provide clear postsurgical radiographic verification of the arterial anastomosis. It is in the form of a metal (e.g., stainless steel) ring which is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAB	Marker, Cardiopulmonary Bypass (Vein Marker)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052642	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 3aee9866-a13e-4c4d-b860-8e3fe3868d13
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: October 03, 2019

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: B7761069619 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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