AccessGUDID - DEVICE: Spetzler Lighted Suction Tube, 5 French, 160mm, Storz Connector (10856312006066)

GUDID

Device Identifier (DI) Information

Brand Name: Spetzler Lighted Suction Tube, 5 French, 160mm, Storz Connector
Version or Model: DN1405-160
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KATALYST SURGICAL LLC

Primary DI Number: 10856312006066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 007883297 *Terms of Use

Device Description: Spetzler Lighted Suction Tube, 5 French, 160mm, Storz Connector

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):	No
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?
38518	Surgical/emergency suction cannula, illuminating, single-use	An atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic, nor an intravascular device; it is not designed for surgical irrigation. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FST	Light, Surgical, Fiberoptic
HBI	Illuminator, Fiberoptic, Surgical Field

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141781	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: 6da0af00-a6fd-475f-932a-8693a51aa6ff
Public Version Date: April 20, 2020
Public Version Number: 5
DI Record Publish Date: July 18, 2016