AccessGUDID - DEVICE: NA (04048551441947)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8404DXC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8404DXC
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551441947
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: C-MAC Video Laryngoscope MIL #0

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):	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?
62762	Rigid non-bladed intubation laryngoscope, video	A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It consists of a thin tubular portion inserted into the ET tube prior to intubation, with an electronic camera at its distal end to transmit anatomical images by a video system to a handle/monitor. It is typically made of memory-alloy material to allow moulding into a shape to facilitate intubation. 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 [?]
Hydrogen Peroxide
Liquid Chemical
High-level Disinfectant

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: 1f2f7794-4486-46e2-89e3-ab2d723e66ae
Public Version Date: April 07, 2025
Public Version Number: 1
DI Record Publish Date: March 28, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +14242188201
Email: regulatory@karlstorz.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES