AccessGUDID - DEVICE: Guide Glide II® Guidewire Introducer Needle (M661S01321275)

GUDID

Device Identifier (DI) Information

Brand Name: Guide Glide II® Guidewire Introducer Needle
Version or Model: S01321-2.759LF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Spectra Medical Devices, LLC

Primary DI Number: M661S01321275
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118301171 *Terms of Use

Device Description: Guide Glide II® Guidewire Introducer Needle One-Wall Style, Green Plastic Hub, B-Bevel Echogenic Tip, Lubricated, Bevel Indicator 21G (0.08 cm) x 2.75 in. (7.0 cm) Accepts guidewire up to 0.021 in. (0.53 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):	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?
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 [?]
K082580	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80c3e081-2f47-45a2-97ae-36a2107ba8e7
Public Version Date: June 19, 2024
Public Version Number: 3
DI Record Publish Date: October 12, 2023