AccessGUDID - DEVICE: Quick-Access™ (M2045190050)

GUDID

Device Identifier (DI) Information

Brand Name: Quick-Access™
Version or Model: 519-005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 519-005
Company Name: Spectranetics Corporation

Primary DI Number: M2045190050
Issuing Agency: HIBCC
Commercial Distribution End Date: February 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: Quick-Access™ Needle Holder

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?
60437	Interventional radiology percutaneous-access kit, single-use	A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. 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 [?]
K112887	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1439cc38-559a-4af3-a017-5287d44cf4f7
Public Version Date: October 10, 2022
Public Version Number: 6
DI Record Publish Date: August 26, 2014