AccessGUDID - DEVICE: Endocraft LLC (00860009975132)

GUDID

Device Identifier (DI) Information

Brand Name: Endocraft LLC
Version or Model: ZVG100A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZVG100A
Company Name: Endocraft, LLC

Primary DI Number: 00860009975132
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039432148 *Terms of Use

Device Description: Zeitels Suspension Gallows positions and holds the laryngoscope and patient in ideal posture for surgery. This suspension mounts to the surgical bed, rather than on the patient's chest.

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?
66249	Rigid laryngoscope positioner	A noninvasive device designed to externally hold and position a rigid laryngoscope on the chest of a patient during an examination or intervention. It consists of a sturdy rod, a laryngoscope connector at one end, and a rubber base at the other end for placement on the patient’s chest to provide support and facilitate alignment of the laryngoscope relative to the patient’s body. 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: 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: 916d43d4-8f9d-44f9-8b7c-4afa28b9c74e
Public Version Date: July 17, 2023
Public Version Number: 1
DI Record Publish Date: July 07, 2023