AccessGUDID - DEVICE: ORLocate (10724995221109)

GUDID

Device Identifier (DI) Information

Brand Name: ORLocate
Version or Model: ORLocate Tonsil Sponge
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSTS78
Company Name: STERIS CORPORATION

Primary DI Number: 10724995221109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 0.875 inch diameter, Sterile is used with the ORLocate Sponge Solution System.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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?
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
GDY	Gauze/sponge, internal, x-ray detectable
NAB	Gauze / sponge,nonresorbable for external use

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.875 Inch

Device Record Status

Public Device Record Key: 7bf6e9d4-e8da-4f1c-aeb3-287eaec43e50
Public Version Date: April 24, 2025
Public Version Number: 2
DI Record Publish Date: December 07, 2022