AccessGUDID - DEVICE: COR-VASC System with articulated arm (Large) (10817121000515)

GUDID

Device Identifier (DI) Information

Brand Name: COR-VASC System with articulated arm (Large)
Version or Model: 1100229
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1100229
Company Name: Coroneo Inc

Primary DI Number: 10817121000515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 255276362 *Terms of Use

Device Description: The COR-VASC system is intended to be used for performing coronary artery bypass surgery on a beating or arrested heart. The system consists of a large adult sternum retractor, a clamping apparatus, and a coronary artery stabilizer.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
45181	Surgical retraction system, reusable	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	Instruments, Surgical, Cardiovascular

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 [?]
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: a34baec0-9e90-40eb-80fb-72c1fc014dcb
Public Version Date: July 14, 2023
Public Version Number: 1
DI Record Publish Date: July 06, 2023