AccessGUDID - DEVICE: Endocraft LLC (00860009975156)

GUDID

Device Identifier (DI) Information

Brand Name: Endocraft LLC
Version or Model: ZIN-100A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZIN-100A
Company Name: Endocraft, LLC

Primary DI Number: 00860009975156
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 039432148 *Terms of Use

Device Description: Zeitels Vocal Fold Infusion Needles are designed for vocal surgery for injection of needed fluid to surgical site.

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?
33427	Laryngeal injection kit	A collection of surgical instruments, pharmaceuticals, and other items (e.g., dressings) intended to be used to perform an injection in the region of the larynx. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAA	Set, Laryngeal Injection

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
Dry Heat Sterilization
Moist Heat or Steam Sterilization

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: 5adaba78-9aa0-4c84-929c-71276ab74736
Public Version Date: July 14, 2023
Public Version Number: 1
DI Record Publish Date: July 06, 2023