AccessGUDID - DEVICE: ORLocate (00724995220679)

GUDID

Device Identifier (DI) Information

Brand Name: ORLocate
Version or Model: ORLocate Tablet
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OX216
Company Name: Steris Corporation

Primary DI Number: 00724995220679
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 177360039 *Terms of Use

Device Description: Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.

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):	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?
61906	Electronic surgical sponge-counter	A hand-held battery-powered computerized device intended to be used in the operating room (OR) by professional staff to electronically maintain the count of surgical sponges/swabbing materials during a surgical procedure to prevent swabs from being inadvertently left in a patient. It typically has controls/keyboard, display and built-in bar-code reader, whereby packs of surgical sponges entering the surgical field are intended to be scanned in and counted out. It may include device for battery recharging or connection to a personal computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWH	Counter, sponge, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 51f89f00-d839-486b-ba46-ea41aee63070
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: December 07, 2022