AccessGUDID - DEVICE: MicroTaper™ NV Non-Vascular Safety Introducer Set (10860327000278)

GUDID

Device Identifier (DI) Information

Brand Name: MicroTaper™ NV Non-Vascular Safety Introducer Set
Version or Model: SA-15-G100-NT-MT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SUMMIT ACCESS LLC

Primary DI Number: 10860327000278
Issuing Agency: GS1
Commercial Distribution End Date: October 08, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 021348782 *Terms of Use

Device Description: No description.

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):	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?
62391	Non-vascular catheter introduction set	A collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGZ	Accessories, Catheter

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: 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: b33065ad-290b-440c-81b0-cacfa4d3f997
Public Version Date: October 09, 2024
Public Version Number: 3
DI Record Publish Date: October 05, 2022