AccessGUDID - DEVICE: Perforated Mayo Tray (00192896118881)

GUDID

Device Identifier (DI) Information

Brand Name: Perforated Mayo Tray
Version or Model: ST15-F-PMT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST15-F-PMT
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896118881
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: Perforated Mayo Tray

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":	Yes
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?
42893	General-purpose bowl, reusable	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRP	TRAY, SURGICAL

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 [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 10.625 Inch
Length: 15.125 Inch
Device Size Text, specify: Height 0.75 Inch

Device Record Status

Public Device Record Key: 3a19a271-de9c-48e8-bde5-19d9016479a5
Public Version Date: August 26, 2024
Public Version Number: 1
DI Record Publish Date: August 16, 2024