AccessGUDID - DEVICE: MICRO-STICK® SET (00884908088663)

GUDID

Device Identifier (DI) Information

Brand Name: MICRO-STICK® SET
Version or Model: RMS19422
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Medical Components, Inc.

Primary DI Number: 00884908088663
Issuing Agency: GS1
Commercial Distribution End Date: June 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: 4F REGULAR MICRO-STICK® INTRODUCER SET WITH STAINLESS STEEL GUIDEWIRE WITH RADIOPAQUE TIP

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?
38128	Vascular dilator, single-use	A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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: f2672f68-e34a-4975-a08d-205fb872857c
Public Version Date: August 20, 2020
Public Version Number: 4
DI Record Publish Date: November 18, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50884908088668	4	30884908088664	2020-06-10	Not in Commercial Distribution	box
30884908088664	10	00884908088663	2020-06-10	Not in Commercial Distribution	inner box