AccessGUDID - DEVICE: ORLocate (00724995220648)

GUDID

Device Identifier (DI) Information

Brand Name: ORLocate
Version or Model: ORLocate Locator
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OX202
Company Name: Steris Corporation

Primary DI Number: 00724995220648
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 177360039 *Terms of Use
Previous DI: 05060356150205

Device Description: OrLocate Locator 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?
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	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: d62f1b08-50f8-4320-9408-9f7db293c157
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: March 14, 2023