AccessGUDID - DEVICE: NA (04055207039694)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 829402
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8294.02
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207039694
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SUCT./IRRIG. DEVICE ID 2MM TL 113MM reusable

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:	No
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?
47625	Surgical irrigation/aspiration tubing set	A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTI	BRONCHOSCOPE ACCESSORY

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Hydrogen Peroxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 113 Millimeter
Lumen/Inner Diameter: 2 Millimeter

Device Record Status

Public Device Record Key: dc7c9b70-98dd-41f3-9dfb-2d402db24a0f
Public Version Date: November 21, 2024
Public Version Number: 6
DI Record Publish Date: September 26, 2016