AccessGUDID - DEVICE: Hayden Medical (00840319747483)

GUDID

Device Identifier (DI) Information

Brand Name: Hayden Medical
Version or Model: 280-104
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 280-104
Company Name: Hayden Medical, Inc.

Primary DI Number: 00840319747483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618214410 *Terms of Use

Device Description: Barr Fistula Probe, with 8" (20cm) sterling shaft, eye at tip, 11-1/2" (28.8cm) overall

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?
62126	Tracheoesophageal fistula gauge	A non-sterile, hand-held, manual non-surgical instrument intended to be transiently inserted into a tracheoesophageal fistula (puncture) for measuring its length to determine appropriate tracheoesophageal speech valve size prior to placement; it may also be intended to temporarily dilate the fistula to facilitate insertion of the speech valve. It a synthetic polymer cylindrical shaft with graduated markings, attached to a handle, designed to be manually inserted via the tracheostoma by a clinician; devices intended to assist insertion may be included. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, surgical, instrument

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
No Device Sizes

Device Record Status

Public Device Record Key: b34e8c70-7cd3-465f-b7c6-35687dba4cc3
Public Version Date: March 30, 2023
Public Version Number: 1
DI Record Publish Date: March 22, 2023