AccessGUDID - DEVICE: NA (04055207010297)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 845601
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8456.01
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207010297
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: OP-LARYNGOSCOPE WL 148MM by Steiner adjustable, dilation prox. min. / max. 32x12.5/ 32x27.5mm, dilation dist. min. / max. 16x13.5/ 16x53mm, TL 200mm, straight blade, outer light carrier and insufflation-suction tube, with universal handle for all support and mounting systems, 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?
15076	Rigid intubation laryngoscope, reusable	A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCW	LARYNGOSCOPE, RIGID

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 148 Millimeter

Device Record Status

Public Device Record Key: 123e8146-0f3b-4514-a467-232089ba4912
Public Version Date: February 29, 2024
Public Version Number: 2
DI Record Publish Date: February 11, 2022