AccessGUDID - DEVICE: ITL Essentials™ Sharps Passing Tray Large (09555240401601)

GUDID

Device Identifier (DI) Information

Brand Name: ITL Essentials™ Sharps Passing Tray Large
Version or Model: A500117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A500117
Company Name: ITL ASIA PACIFIC SDN. BHD.

Primary DI Number: 09555240401601
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 597723837 *Terms of Use

Device Description: ITL Essentials™ Sharps Passing Tray Large is the sterile version of Sharps Passing Tray Large which is used for safe transfer of sharp surgical instruments during surgery. For single use only.

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):	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?
12236	Surgical instrument interim-placement holder, single-use	A device intended to be used in the operating room (OR) by staff to safely hold a hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors, robotic system instrument hand-held remote controller] when not in use during surgery, to avoid damage to the instrument, maintain its sterility, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep Away from Direct Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ff81914-68f4-4b2c-a4ca-8282ce50ed6e
Public Version Date: July 27, 2023
Public Version Number: 1
DI Record Publish Date: July 19, 2023