AccessGUDID - DEVICE: METAL INSTRUMENT TRAY (00192896071117)

GUDID

Device Identifier (DI) Information

Brand Name: METAL INSTRUMENT TRAY
Version or Model: STE2-302
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STE2-302
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896071117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: METAL INSTRUMENT TRAY HEAVY DUTY SEAMLESS COVERED CORNERS

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?
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 [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 13.875 Inch
Height: 2.5 Inch
Width: 12.875 Inch

Device Record Status

Public Device Record Key: 569af1cc-c4a5-41bd-920b-ff6f2e663ffa
Public Version Date: October 29, 2021
Public Version Number: 2
DI Record Publish Date: September 10, 2018