AccessGUDID - DEVICE: Novo Surgical (G586N688847C0)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: N6888-47C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G586N688847C0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: cone ventricular needles, w/ 2 holes, luer lock hub, 3-1/2" (9.0 cm), 12 gauge, w/ scale

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:	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?
10847	External ventricular circulatory assist system	An assembly of devices intended to assist a damaged or weakened heart (e.g., one affected by cardiogenic shock) to pump blood. It includes a electrically-powered external pump, an atrial or ventricular cannula to draw blood outside the body, a cannula to deliver the blood back to the aorta or pulmonary artery (depending on left or right ventricular assistance), and a unit that controls pump operation. It is typically intended to be used as a bridge to heart transplantation; it is not intended for cardiopulmonary bypass.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCD	Cannula, Ventricular

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: f2785505-508a-4276-a5e5-0e31c4e9a4ce
Public Version Date: October 23, 2024
Public Version Number: 1
DI Record Publish Date: October 15, 2024