AccessGUDID - DEVICE: 2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD (00884908087666)

GUDID

Device Identifier (DI) Information

Brand Name: 2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD
Version or Model: MR190521
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MR190521
Company Name: Medical Components, Inc.

Primary DI Number: 00884908087666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: 5F (1.0 MM ID) X 9CM5F (1.0 MM I REGULAR MICRO-STICK® INTRODUCER SETINTRODUCER SET WITH NITINOL GUIDEWIREWITH NITIN WITH RADIOPAQUE TIPWITH RADIOPAQ

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":	Yes
For Single-Use:	Yes
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?
61502	Vascular catheter introduction needle	A sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). 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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 658e0660-75bc-4449-b96e-d4973e4add2f
Public Version Date: June 06, 2024
Public Version Number: 4
DI Record Publish Date: October 24, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30884908087667	10	00884908087666	2021-01-29	Not in Commercial Distribution	inner box
50884908087661	4	30884908087667	2021-01-29	Not in Commercial Distribution	box