AccessGUDID - DEVICE: Scanlan® A/C LOCATOR® graft markers (00846159025651)

GUDID

Device Identifier (DI) Information

Brand Name: Scanlan® A/C LOCATOR® graft markers
Version or Model: 1001-83B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1001-83B
Company Name: SCANLAN INTERNATIONAL INC

Primary DI Number: 00846159025651
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 023055619 *Terms of Use

Device Description: U-shaped style, silicone, bulk NS, 10 per pk

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60867	Polymeric 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 synthetic polymer ring (e.g., silicone) impregnated with a metal [e.g., tungsten (W)] to aid visualization, and 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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: 3b64a25c-fc78-4d0f-aa18-fefef60ddbe9
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: August 27, 2015