AccessGUDID - DEVICE: MEDRAD® Stellant CT Injection System (00616258008943)

GUDID

Device Identifier (DI) Information

Brand Name: MEDRAD® Stellant CT Injection System
Version or Model: Stellant D-CE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCT-310, SCT-321, SCT-322
Company Name: BAYER MEDICAL CARE INC.

Primary DI Number: 00616258008943
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058716649 *Terms of Use

Device Description: "DUAL STELLANT W/CERTEGRA WKS (60726807)"

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
57999	CT contrast medium injection system, line-powered, mobile	An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of mains electricity (AC-powered) electromechanical injectors (e.g., syringe piston drivers, tubing roller pumps) capable of delivering media with the pressure, flow range, and volume required for CT studies, and is mobile (e.g., on a wheeled pedestal). The system may synchronize media delivery with the x-ray generator during CT scanning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXT	Injector And Syringe, Angiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082905	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: aee5f954-014b-4f49-9109-c1e313639802
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016