AccessGUDID - DEVICE: Regulus Introducer Set with Hemostatic Valve (07640168110215)

GUDID

Device Identifier (DI) Information

Brand Name: Regulus Introducer Set with Hemostatic Valve
Version or Model: SYM-IS-003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SYM-IS-003
Company Name: Oscor Inc.

Primary DI Number: 07640168110215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101835833 *Terms of Use

Device Description: Introducer Set with Hemostatic Valve 6.3 mm

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:	Yes
Prescription Use (Rx):	No
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?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140917	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Guidewire Compatibility 0.035 in (0.89 mm)
Device Size Text, specify: Dilator Length 35 cm
Device Size Text, specify: Sheath Length 30 cm
Lumen/Inner Diameter: 6.3 Millimeter

Device Record Status

Public Device Record Key: 8ac53443-1e65-4388-91d3-fa5e8420063d
Public Version Date: March 20, 2024
Public Version Number: 5
DI Record Publish Date: November 30, 2017